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Validation Engineer  [ 34874 ]

Job Category:  Validation   Listed on: 08/19/2019
Location:  Summit , NJ 07901

Validation Engineer

Position Overview:

The Validation Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

Essential Functions:

Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
• Develops protocols, and associated reports while adhering to a change management process.
• Supports the execution of equipment qualifications and validation protocols
• Supervises vendors for qualification functions.
• Develops written procedures for calibration and preventive maintenance of equipment
• Supports calibration, equipment qualification and validation activities.
• Configures and documents the configuration of computerized systems
• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
• Manages projects of varying scope and complexity.
• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems
• Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
• Completes all calibration, qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.
• Provides excellent customer service and support.
• Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
• Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
• Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

Required Competencies-Knowledge, Skills, and Abilities:

Knowledge, Skills & Abilities:

• Strong working knowledge of MS Windows client and server technologies.
• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
• Ability to work with the end user to identify and document User and Functional

Requirements:
• Knowledge of pharmaceutical laboratory and manufacturing systems.
• Experience executing equipment qualification documents
• Ability to interact effectively with laboratory, QA, and Facilities groups
• Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
• Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation
• Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.

Competencies:
• Technical / Professional Knowledge
• Problem Solving / Troubleshooting
• Action Oriented
• Attention to Detail
• Multi-tasking
• Building Relationships

Education & Experience:
• BS degree in Engineering or equivalent
• Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV

Working Conditions:
Environmental Conditions:
• Environment may include working in office or in a laboratory / manufacturing area.
• Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
• Ability to work safely when working alone, or working with others.

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Operations  [ 34878 ]

Job Category:  Operations Manager   Listed on: 08/19/2019
Location:  Summit , NJ 07901

Consent Specialist, Biospecimen Operations

PREREQUISITES: Bachelors Degree in a life sciences or healthcare related field with 6+ years related professional experience in an academic clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Summary/Scope

The Biospecimen Operations (BSO) group focuses on management of biospecimens for Celgene sponsored clinical trials. The Consent Specialist will focus on patient informed consent and the management of consent parameters that govern the retention period, use and re-use of biospecimens collected during the course of a clinical trial.
This role will support the BSO Executive Director as a subject-matter expert in patient informed consent and regulatory topics around biospecimens from the perspective of Institutional Review Boards (IRBs), Ethics Committees (ECs), International Health Authorities and country laws/regulations. The Consent Specialist will be expected to optimize processes around interpreting and documenting clinical trial biospecimen consent parameters from study, country and site-specific consent templates for a specific study and upload these parameters into a technology tool.

The Consent Specialist will act as a mentor to peers and is expected to assist them with consent related IRB/EC queries as well as provide training to help develop a group of consent experts within BSO.

Responsibilities will include, but are not limited to, the following:

The Consent Specialist in BSO is expected to review consent documents and interpret consent allowable uses and retention periods in order to maintain adherence to the collection, retention and utilization of biospecimens in line with the informed consent signed by the subject. In doing so, the incumbent is expected to stay current on the broader regulatory landscape related to biospecimens.

• Apply subject matter expertise to the review of informed consent documents, including study, regional, country, and site-level documents, and summarize information regarding use and retention
• Guide CROs and clinical teams on the proper use of protocol and informed consent template materials for the collection and use of biospecimens in Celgene clinical studies
• Provide support for resolving IRB/IEC queries related to biospecimens for Celgene clinical studies
• Assist with the development and updating of policies, standard operating procedures (SOPs) and working procedures (WPs) related to consent oversight. Be able to identify complex biospecimen-related consent permissions. Play a key role in planning and designing clinical trial and biospecimen operations support internally and externally.
• Utilize software tools to track consent parameters, verify and document consent prior to release for utilization, and ensure compliant utilization of biospecimens by following written procedures

Skills/Knowledge Required:

The incumbent should have proficient skills in each of the following areas and have demonstrated application in the context of clinical trials and biospecimen management.

• Clinical Trials: Proficient knowledge of FDA regulatory requirements and GCP; have a demonstrated, intuitive understanding of clinical trials.
• Biobanking: Understanding of global biobanking issues; proficient experience working in organizations adhering to quality standards and working with regulations pertaining to general biospecimen transportation requirements.
• Informed Consent: Subject-matter expertise in patient informed consent and regulatory topics around biospecimens from the perspective of Institutional Review Boards (IRBs), Ethics Committees (ECs), International Health Authorities and country laws/regulations
• Drug Development: Proficient understanding of the drug development process.
• Professional inter-personal skills and excellent oral/written communication. Experienced in presenting to internal and external audiences.
• Basic leadership skills in conflict management, facilitation and negotiation.
• Proficient computer skills in Microsoft Office.
• Experience with consent tracking databases preferred.

Up to 10% travel to conferences to stay up to date on global regulations on biospecimens. The travel is not known at this time but may be required. It could include international travel given one of the legal groups the manager works with extensively is in Switzerland but more likely will be in the US.

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Training Coordinator  [ 34880 ]

Job Category:  Trainer   Listed on: 08/19/2019
Location:  Summit , NJ 07901

Sr. Training Specialist

• Designs and develops training materials for policies, standard operating procedures and/or other compliance related procedures
• Designs and develops eLearning training materials for distribution via the learning management system (LMS) including effectiveness checks
• Provides day to day assistance with the training process including:
o data entry into the LMS (ComplianceWire experience a must)
o run reports from the LMS (ComplianceWire experience a must)
o maintaining all documentation related to procedural/compliance training in a local share drive
• Performs all other tasks as assigned

Required Competencies: Knowledge, Skills, and Abilities:

• High degree of computer skills to increase department's productivity.
• Advanced skills in using MS Outlook, Word, Excel and PowerPoint.
• Intermediate skills in design, development, and implementation of training courses using Articulate.
• Intermediate knowledge of working with computerized systems.
• Intermediate skills to navigate Learning Management System (LMS)
• Intermediate organizational and time management skills.
• Basic writing skills and ability to follow instructions.
• Strong customer focus, collaboration skills, and the ability to drive results and manage complexity
• Strong Interpersonal skills and ability to interact constructively within a matrix organization

Education and Experience:

• Bachelor’s degree preferred
• 1 year of experience in a pharmaceutical (or other applicable regulated healthcare industry) compliance role
• At least 3 years’ relevant work experience required
An equivalent combination of education and experience may substitute

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Portfolio Analyst  [ 34884 ]

Job Category:  Specific   Listed on: 08/19/2019
Location:  Summit , NJ 07901

Portfolio Operations Analyst: Financial Quality Assurance
Typical Daily Work Hours = 9am to 5pm (some flexibility in start/end times)
Weekend & OT work not required.
100% onsite work.

In addition to the skills below this resource will be expected to work with a team of resources and handle ad-hoc requests. Experience working within an Agile environment or Waterfall Project management a must for understanding the customers. Experience as a strategic consultant and the ability anticipate the needs of our customers from the perspective of managing Project Financials is a plus.

Advanced Excel skills:
Analysis with pivot tables
Vlookups, tables, understanding and presenting predefined data
Macros a plus

Business Analyst Skills:
An understanding of the fundamentals of Project financial Management vs. Corporate finances
The ability to work with resources and identify flaws in how they are tracking or reporting project financial data
The ability to work in aggregated toolsets and identify trends of information (e.g., everyone is reporting X wrong so we need to re-train them on how to report X)
Provide ad-hoc reporting or general data cleansing outside of the scope of project financials
Documents the processes (technical and business) via best practices in a playbook or other sources
Experience with Agile development and working with tools like JIRA a plus

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Lab Technician  [ 34888 ]

Job Category:  Technical   Listed on: 08/19/2019
Location:  Summit , NJ 07901

The ECQ LC Specialist supports the successful operation of Waters and Agilent HPLC, UPLC and LCMS systems through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems associated with HPLC, UPLC and LCMS systems. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. The incumbent may be asked to lead small to medium sized projects in their area of responsibility, and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit. The incumbent may be involved with writing deviations, investigations and supporting the implementation of change controls.


Essential Functions:
1) Operational Activities
a. Executes HPLC, UPLC and LCMS calibrations, maintenances, repairs, and requalification activities in laboratory areas.
b. Demonstrated proficiency for calibration, preventative maintenance, and qualification functions as related to Waters and Agilent HPLC, UPLC, and LCMS systems.
c. Coordinates/supervises LC vendors for calibration, preventative maintenance, and qualification functions.
d. Reviews and approves LC vendor executed calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to Celgene standards.
e. Works closely with, and enters data into the site CMMS system.
f. Ensures all LC calibration, PM, and qualification records are filed appropriately after approval.
g. Writes and supports deviations and investigations that result from LC qualification failures, if applicable, along with developing and supporting the implementation of corrective and preventative actions.
h. Support the development, revision and review of written LC procedures for calibration, preventive maintenance and requalification of equipment.
i. Support the development, review and approval of LC calibration and maintenance plans in site CMMS system.
j. Supports the execution of LC qualifications and process improvement studies.
k. Adheres to all policies and procedures which govern the ECQ team and the LC equipment they manage to ensure compliance is held to the highest standard.

2) Promotes and provides excellent customer service and support
a. Regularly reviews, prioritizes and promptly responds to customer LC maintenance, repair and support requests.
b. Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met.
c. Maintains a positive relationship with all the members of the ECQ department and site customers while promoting a positive team environment.

3) Inventory Management
a. Work with planning group to ensure CMMS system is updated as LC calibration, maintenance and requalification activities are performed.

4) Regulatory Responsibilities
a. Maintains all required Corporate, Facilities and EHS training as required.
b. Adheres to all safety procedures and hazard communication.
c. May be called upon to act as Subject Matter Expert in both internal and regulatory audits.

Required Competencies-Knowledge, Skills, and Abilities:

Knowledge, Skills & Abilities:
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of Waters and Agilent HPLC, UPLC and LCMS systems.
• Strong written and verbal communication skills.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Working knowledge of inventory management systems (CMMS), mainly Blue Mountain RAM.
• Ability to interact effectively with laboratory, QA, and Facilities groups.

Competencies:
• Professional Knowledge
• Problem Solving
• Team Player / Building Relationships
• Multi-tasking
• Customer Focus
• Action and detail oriented
• Active Listening

Education & Experience:
• BS in Engineering or Science related discipline preferred.
• Minimum 5 years of experience performing qualification, maintenance and repairs of Waters and Agilent LC equipment in FDA-regulated industry required.
• LC instrumentation background and experience in laboratory operations.
• Knowledge of cGMP in the pharmaceutical industry.
• Excellent computer skills including knowledge of calibration management.
• Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
• Experience writing and supporting deviations and investigations preferred.

Working Conditions:
Physical / Mental Demands:
• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
• Ability to sit, stand, walk and move within workspace for extended periods
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.

Environmental Conditions:
• Will likely spend 70% of their time in a laboratory environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Ability to work safely and effectively when working alone, or working with others.

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ECQ Planner  [ 34890 ]

Job Category:  Specific   Listed on: 08/19/2019
Location:  Summit , NJ 07901

The ECQ Planner supports the successful operation of the GMP facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, will be responsible for planning validation and maintenance activities related to both GMP and non GMP laboratory and process equipment. The incumbent will be responsible for receiving, coordinating and planning work related to on-demand work orders and routine scheduled maintenances. The incumbent will also coordinate work with outside vendors and serve as an escort for vendor performed maintenance at times. The incumbent will work heavily in the CMMS, Blue Mountain RAM, and will be responsible for entering data, pulling schedules and reports. The incumbent in this role will have specific job tasks and processes to follow to perform their job. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action.

Essential Functions:
Scheduling Responsibilities
• Work with equipment operations team to plan and schedule routine equipment calibrations, preventative maintenance and requalification activities.
• Serve as the first point of contact for any on demand work orders generated by the laboratory community.
• Field any on demand work requests. Assess priority and assign and respond as needed.
• Work with equipment operations team to schedule and prioritize all on demand equipment work orders.
• Interface with OEM (Original Equipment Manufacturer) to schedule routine and on demand work requests, to request spare parts and expedite services as required.
• Confirm that incoming vendors are appropriately trained for work that is being performed.
• Escort vendors on site as needed to facilitate completion of work.
• Assist delivery team to schedule purchase, install, commissioning and qualification of new equipment and facilities.

Inventory Management in CMMS System
• Enter, create and modify data in the site CMMS system, Blue Mountain RAM.

Service Contract Support
• Assist with the management of Vendor service contracts to support equipment and systems
• Provide feedback to departmental leadership on vendor performance and needs.

Departmental Metrics / KPI’s
• May be asked to pull data and reports from Blue Mountain RAM system to assist in the development of staff metrics.
• Maintain and update metrics monthly.


Preventative Maintenance Work Plans
• Manages new, revised or deactivation of preventative maintenance work plans associated with assets within CMMS
• Generate PM work orders within the CMMS and issues to the responsible departments
• Coordinates PM work orders with the affected departments or outside vendors if necessary
• Closure of preventative work orders

Demand Maintenance Management
• Manage demand maintenance requests from customers and internal staff within CMMS
• Communicate with our customers to provide updates and clarifications if necessary
• Generate demand work orders within the CMMS and issues to the responsible groups
• Coordinates demand work orders with the affected departments or outside vendors if necessary


Promotes and maintains compliance with corporate, safety, security and regulatory policies
• Maintains all assigned Corporate, Facilities, GMP and EHS training as required



Required Competencies-Knowledge, Skills, and Abilities:

Knowledge, Skills & Abilities:
• Strong knowledge of facility management systems such as CMMS (Computerized Maintenance Management Systems).
• Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Familiarity with FDA / cGXP environments and associated compliance regulations
• Adept in Microsoft Office Suite – Word, PowerPoint, Excel and Outlook, and the ability to learn new software, such as enterprise business, building management, security, and maintenance management systems.
• Proficient at writing well-formulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors. Ability to follow oral and written instructions, read, interpret and update engineering manuals/drawings relevant to the trade or the assigned task
• Self-starter who is able to work both independently without direct supervision or in a team environment
Competencies:
• Technical Knowledge
• Problem Solving / Troubleshooting
• Team Player
• Multi-tasking
• Customer Focus
• Action Oriented / Tenacity

Education & Experience
• AA / AS degree or acceptable trade certification from technical
• Minimum 3-5 years of facilities maintenance/ operations experience at and industrial or commercial site or related experience and/or equivalent combination of education and experience
• GMP facility experience preferred



Working Conditions:
Physical / Mental Demands:
• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 50lbs
• Ability to sit, stand, walk and move within workspace for extended periods
• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling

Environmental Conditions:
• Primarily office environment
• Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
• Ability to work safely when working alone or working with others.

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Technical Writer  [ 34810 ]

Job Category:  Specific   Listed on: 06/25/2019
Location:  Summit , NJ 07901

Bachelor’s degree required. 5+ years experience as an Instructional Designer in a healthcare or pharmaceutical environment preferred. Experience with e-Learning authoring tools a
must. Knowledge of Articulate 360 (Storyline) a must. Knowledge of REMS processes and user experience design a plus.
This position designs and develops training materials, edits, and maintains all training content for all U.S. REMS functional roles.

Instructional Design
• Create and maintain training materials for Trainers for all U.S. REMS departmental roles
• In conjunction with subject matter experts, develop departmental training topics
• Continually update all U.S. REMS content and training materials to include all technology and procedural changes as they occur
• Assist with development of all departmental presentations and handouts and circulate through the official approval process prior to deployment to the staff
• Introduce innovative delivery methods of training, track success upon implementation, and provide metrics to management
• Develop instructor-led course activities and reinforcement games
• Create internal training notifications when requested and circulate among appropriate management teams prior to delivery to staff
• Assist Training Team with the creation of sample data for upcoming training classes when necessary
• Measure effectiveness of training by:
o Communicating with the Training Team, and Customer Care management teams on a regular basis
o Tracking items that are most difficult to cover and time consuming and proposing solutions to make the training more efficient and effective
o Sending out surveys to U.S. REMS staff to better understand most desirable delivery methods and propose solutions for additional training methods to be considered
• Assist with maintenance of departmental document control system for new documents and revisions
• Deploy training modules through LMS and track completion to ensure applicable staff members are up to date
• Other tasks as assigned


Technology
• Vet out new and improved eLearning opportunities for U.S. REMS and offer possible solutions based on research; consult with external Celgene departments to understand what systems work best for them and propose viable options for U.S. REMS
• Understand best training practices, discuss with Training Manager and implement upon approval


Responsibilities include, but are not limited to the following:
Online Knowledge Sharing System
• Create, edit, and revise system, process and procedural content for U.S. REMS
• Initiate document review cycles through SharePoint
• Implement final documents and ensure that document history and version control is applied
• Assign effective dates to documents
• Load training materials into the training delivery system, track training activity and deliver metrics to Training Manager on a regular basis
• Continually investigate ways to improve overall user experience

Skills/Knowledge Required:

• Strong analytical, problem-solving and decision-making skills
• Excellent knowledge of Microsoft Word, Excel and Power Point
• Excellent knowledge of e-Learning authoring tools such as Articulate 360 (Storyline), Captivate, Camtasia
• Detailed knowledge of SharePoint; knowledge of SupportPoint a plus
• Experience creating and maintaining instructional materials and facilitator guides is essential
• Experience documenting change history is required
• A leader with excellent communication skills (both oral and written) and the ability to communicate across multiple levels of the organization
• Group facilitation skills required with the ability to also work independently in a fast paced, changing environment
• Ability to remain organized with multiple tasks occurring simultaneously; project management skills a plus
• Integrity, flexibility, positive attitude and a strong work ethic required
• High level of motivation and initiative
• Great time management and prioritization skills a must
• Minimal travel required

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Facilities Specialist  [ 34800 ]

Job Category:  Specific   Listed on: 06/25/2019
Location:  Summit , NJ 07901

The Facility Specialist will support the engineering department with procurement, installation, and qualification of equipment for cGMP manufacturing and laboratory use.

Meets with end user to develop User Requirement Brief. Develops estimate for total installed cost including site preparation (electrical, plumbing, data transfer, emergency power, etc.).

Works with contractors to procure and oversee site prep activities.

Communicates with all stakeholders, including Procurement, EHS, QA, Validation, and Engineering.

Overall management of capital projects, construction, engineering design, and qualification.

Requirements:
Engineering degree with minimum 5 years’ experience in FDA regulated environment preferred.

Excellent organization and communication skills required.

• Basic computer skills (Word, Excel, PowerPoint, Microsoft Project, Visio)
• Project management experience
• Excellent interpersonal skills
• Excellent organizational skills
• Knowledge of FDA regulations
• Basic knowledge of local, state and federal building codes?

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Senior Business Analysts  [ 32560 ]

Job Category:  Business Analyst   Listed on: 06/02/2019
Location:  Union , NJ 07083

Perform bus reqt elicitation, analysis & prioritization, bus process redesign, system testing & implementation. Work w/ relevant s/w technologies incl MS Office, MS Project, Visio or similar diagramming tool, & Excel.

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Validation Engineers  [ 10009 ]

Job Category:  Validation   Listed on: 06/02/2019
Location:  Union , NJ

Author assigned validation docs.  Develop bus. process maps, user req. spec’s, functional req. spec’s, & procedural spec’s.  Review compiled validation package.

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Senior Validation Engineers  [ 10010 ]

Job Category:  Validation   Listed on: 06/02/2019
Location:  Union , NJ

Author & review assigned validation docs.  Review bus. process maps, user req. spec’s, functional req. spec’s, & procedural spec’s. Lead project team & service providers to attain project goals, objectives & milestones. 

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Sales Engineers  [ 25013 ]

Job Category:  Software Engineer   Listed on: 06/02/2019
Location:  Union , NJ 07083

Develop financial & operational estimates based on info gathered from potential customers. Analyze & report on customer behaviors regarding utilization of services. Work w/ .NET, ASP.NET, Java, Oracle, C#, VBA & SQL Server.

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Programmer Analysts  [ 6200 ]

Job Category:  Programmer   Listed on: 06/02/2019
Location:  Union , NJ

Develop & test s/w programs.  Analyze & review user requests for modification.  Program, debug & document systems.  Work w/ relevant s/w languages & technologies. 
All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Computer & Information Systems Mgrs  [ 25012 ]

Job Category:  Information Security Consultant   Listed on: 06/02/2019
Location:  Union , NJ 07083

Plan, coordinate & direct design of computer apps.  Monitor & control project teams’ progress & provide mgmnt oversight. Work w/ MS Project, MS Visio, Oracle, .Net Framework, Erwin, SQL Server.  Travel/relocate to various unanticipated locations to interact with clients and train end users for different long and short term assignments. 

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.                      

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Senior Validation Engineers-Pharmaceutical Systems  [ 31912 ]

Job Category:  Validation   Listed on: 06/02/2019
Location:  Union , NJ

Create validation lifecycle deliverables. Review user & functional specifications, design/configuration specifications, SOPs, & change requests. Develop validation protocols (IQ, OQ, PQ) & create/review test plans, test scripts & traceability matrices. 

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Senior Drug Safety Specialists  [ 32869 ]

Job Category:  Drug Safety   Listed on: 06/02/2019
Location:  Union , NJ 07083

Senior Drug Safety Specialists: Collect, enter data and submit (to FDA) study and post-marketing adverse event drug/device reports received from clinical sites, call centers & GPVs per Local SOPs and Study Protocols. Provide guidance to US PV team on data entry of study cases. Train and mentor new hires on safety database and other applications.

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Drug Safety Specialists  [ 32868 ]

Job Category:  Drug Safety   Listed on: 06/02/2019
Location:  Union , NJ 07083

Drug Safety Specialists: Administer the electronic adverse event database & validated tracking spreadsheets. Collect, enter data and submit (to FDA) study and post-marketing adverse event drug/device reports received from clinical sites, call centers & GPVs per Local SOPs and Study Protocols.

All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Research Associate  [ 34780 ]

Job Category:  Research Associate   Listed on: 06/02/2019
Location:  Union , NJ

Carry out lab experiments & analysis for analytical development, as well as provide analytical support for process development & quality control. Conduct experiments/analysis independently & may assist other scientists/analysts with experiments.

Multiple positions available. All jobs located in the Union, NJ area & require traveling beyond commuting distance & possible relocation.

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Lab Systems  [ 34633 ]

Job Category:  Specific   Listed on: 04/12/2019
Location:  Morris Plains , NJ 07950

Desktop Lab Systems Engineer

Experience in Pharmaceutical GxP regulated lab area. Perform installation and support of various standalone laboratory instruments following SDLC methodology and utilizing reusable validation tools.


Responsibilities:
• Execution installations of instrument builds/images on laboratory workstations
o Ensure all desktop software is installed, communicating as intended
o Complete desktop installation(s) documentation and collect necessary supporting evidence
• Review instrument software requirements ensuring compatibility and compliance prior to installation
• Troubleshoot and issues that arise during installation or during operational use
• Update installation documentation as necessary to accommodate new or changed requirements
• Ensure resources performing IT activities are knowledgeable of and in tune with latest company policies and Health Authority Regulated (HAR) regulations
• Provide input and guidance for technical strategy as it relates to all GMP computerized systems and address any compliance gaps.
• Ensure all computerized systems remain in compliance post-production
• Troubleshoot client instrument workstation and information technology issues
• Provide feedback and suggestions to the client for future process improvements

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Reliability Engineer  [ 34659 ]

Job Category:  Specific   Listed on: 04/12/2019
Location:  Morris Plains , NJ 07950

Reliability Engineer

Originates and develops analysis methods to determine reliability of components, equipment and processes. Acquires and analyzes data. Prepares diagrams, charts, drawings, calculations and reports to define reliability problems and make recommendations for improvements. Conducts an analysis of reliability problems and investigates to determine the required reliability approach for the particular situation, with consideration given to the cost limitations for equipment uptime/downtime, repair/replacement costs and weight, size and availability of materials/equipment. Determines cost advantages of alternatives and develops action plans that comply with internal/external customer demands for reliability processes/equipment to avoid failures.

Education: B.S. degree in engineering, statistics, mathematics, or equivalent

Experience: Entry level with three to 10 years’ experience

Position Responsibility:
Works under general direction of project engineers or section head, or under general administrative instruction in performing detailed reliability studies and calculations of component/system reliabilities.
Considers impact of costs on recommended action plans for avoiding/correcting problems during the design phase or remedial action for correcting reliability problems on installed equipment; performs root cause failure analysis to help prevent failures.

Plans and performs engineering research, design development, or manufacturing/process engineering assignments, including responsibility for major subsections of complex projects using general engineering practices influenced by the general theme of reliability principles.

Estimates engineering personnel needs and coordinates and supervises the use of other engineers and technicians to accomplish the objective of cost-effective reliability improvements for projects.

Recognizes that assignments are broad in nature and require appreciable originality and ingenuity to complete them and considerable latitude for unreviewed actions or decisions.

Follows company safety and health guidelines and other company policies.

Performs other work as assigned.

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Project Manager  [ 34660 ]

Job Category:  Project Manager   Listed on: 04/12/2019
Location:  Morris Plains , NJ 07950

Need a PM to manage a server upgrade project that will require management of the server configuration, os install, application install and any validation work that will be required.

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Pharmaceutical Change Engineer  [ 32801 ]

Job Category:  Regulatory   Listed on: 04/07/2019
Location:  Union , NJ 07083

Review, approve & provide regulatory triage to change management for records as a quality supporter supporting manufacturing, packaging, testing and release of clinical supplies in GxP environment. Review & approve temporary changes as well as support effort to improve change management. Review/approve GMP Lifecycle Documentation.

Travel/reloc. to various unanticipated locations as req’d.

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