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Operations  [ 35020 ]

Job Category:  Operations Manager   Listed on: 10/22/2019
Location:  Summit , NJ 07901

The incumbent will be responsible for the execution of corporate inventory strategy across all client inventory locations in the Americas region with over 10 Oracle warehouse and distribution sites which will include all Celgene brands and stock keeping units. Responsibilities will include, but are not limited to, the following: ? Collaboration with internal customers and logistics service providers, including but not limited to Corporate and Site Planning, Site Manufacturing Management, Site Warehouse Management, Order Management, Logistics, Costing, Internal Audit and Quality Assurance. - Maintain subject matter expertise for all Inventory Management functions in Oracle - Maintain subject matter expertise and manage EDI transactional activity with LSP's. - Interface with Cost Accounting and Internal Audit to coordinate, manage and perform physical inventory counts as required. - Perform analytical assessments of inventory levels across all sites and develop and execute plans to maintain strategic inventory levels. - Validate inventory movements with proper shipping and receiving documentation from all sites. - Assure that all physical and electronic inventory movements are coordinated and executed on a timely basis. - Develop, Track /Manage and report key performance indicator metrics to identify and facilitate continuous process improvement - Develop, author and maintain SOP's. - Distribute reports to internal and external clients as necessary - Proactively identify strategic and operational issues and develop proposals outlining solutions. - Perform all transactions related to inventory management. Skills/Knowledge Required: - College degree in business or related field. - Individual should be detail oriented and able to multi-task - 2 years experience in warehousing, inventory control distribution or packaging experience required. - Prior EBS systems experience required (Oracle preferred) ? Proficiency in MS Office required - Excellent written and verbal communication skills ? Prior supervisory experience preferred - Up to 25% domestic travel required.

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Regulatory Affairs  [ 35018 ]

Job Category:  Regulatory   Listed on: 10/22/2019
Location:  Summit , NJ 07901

AD PROMO REVIEWER REG AFFAIRS

Summary/Scope:
Responsibilities will include, but are not limited to, the following:
• Supports interactions with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned product(s).
• With oversight from Director level or above, develop regulatory strategies and provide guidance to other departments.
• Manage timelines and resources to achieve stated goals.
• Foster and facilitate teamwork between regulatory, legal, medical and commercial colleagues participating the Promotional Review (PACT) process.
• Assess regulatory risk and develop mitigation strategies with oversight.
• Provide regulatory advice and support to commercial teams and (PACT), with oversight.
• Develop departmental guidance and procedures.
• Manage regulatory aspects of the copy review / approval process for product promotional materials for assigned products, indications, or audiences. Ensure compliance of promotional materials with the governing FDA regulations, and ensure submission of promotional materials to OPDP in a timely fashion.
• Design and conduct departmental training
• Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Celgene’s pharmaceutical products. Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape.

Key Requirements/Knowledge:

• Bachelors degree (BA or BS). Scientific discipline preferred.
• 3-7 years of pharmaceutical industry experience, including 2-4 years in regulatory affairs.
• Knowledge of FDA advertising and promotional regulations and guidance is necessary.
• Must be able to innovate, analyze, and solve problems with minimal supervisory input.
• Excellent communications, listening, and negotiation skills are necessary.
• Leadership skills required.
• Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
• Must be an innovator of new ideas and best practices
• Must recognize potential problems
• Must have outstanding attention to detail.

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Regulatory Affairs  [ 35019 ]

Job Category:  Regulatory   Listed on: 10/22/2019
Location:  Summit , NJ 07901

Responsibilities will include, but are not limited to, the following:
• Provide promotional labeling and advertising review support to Regulatory Affairs Reviewers.
• Pre-review of assigned promotional material in an electronic review system
• Proofread final laser copy to ensure all Copy Review Committee (CRC) comments have be incorporated.
• Final QC review and approval of promotional material and preparation of submissions to FDA for preclearance and initial use (Form FDA 2253)
• Primary contact for marketing operations.
• Maintain Regulatory Affairs Compliance of promotional material through tracking and monitoring.
• Attend high priority Copy Review Committee meetings to assist Regulatory Affairs Reviewers.
• Participate in proofreading of product labeling components, package inserts, brief summaries as required by requested deadlines

Skills/Knowledge Required:

• Bachelor Degree or 2-4 years pharmaceutical industry experience
• Basic understanding of pharmaceutical advertising requirements.
• Exceptional attention to detail is critical for this job.
• Experienced with proofreading technical documents.
• Excellent interpersonal skills. Accurate and concise oral communications and writing ability.
• Excellent organizational and time management skills.
• Ability to multitask and meet strict deadlines.
• Must be able to innovate, analyze and solve problems.

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Validation  [ 35007 ]

Job Category:  Validation   Listed on: 10/22/2019
Location:  Summit , NJ 07901

Actual Job Title = Sr. Validation Engineer
100% onsite work.

Position Overview:

The Equipment 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:
• 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 working knowledge of MS Windows client and server technologies.
• 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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Systems Analyst  [ 35010 ]

Job Category:  Systems Analyst   Listed on: 10/22/2019
Location:  Summit , NJ 07901

• Experience in Hyperion Suite of Technologies (Essbase, Planning and Financial Reporting).
• Expertise in Hyperion Oracle EPM 11.x - Design and Development of EPM Applications using Hyperion Essbase, Planning, FDMEE and ODI.
• Expertise in Hyperion Infrastructure Setup – Installation and Configuration of Hyperion environment for components: Essbase, Planning, Reporting, FDM, FDMEE, ODI, DRM etc.
• Expertise in Hyperion upgrades in Heterogeneous platforms and proven expertise in upgrades with different approaches.
• Expertise in Design Assessment, Calculation Code Review & Optimization, Performance Assessment and Performance Tuning.
• Experience in Hyperion Essbase Application Manager modules; Outline Editor, Report Editor, Calc Script Editor, and Data Prep Editor.
• Experience in developing Hyperion Financial Reports.
• Experience in Database optimization in the context of Data Loading, Business Rules, Calculation Scripts, and Report Scripts.
• Experience in Building Dimension , Attributes using rule files and loading Fact data in an ESSBASE Applications by as generation, level, parent-child references etc..
• Experience in developing planning solutions that is able to handle Multiple Currencies and related calculations.
• Extensive experience on server settings, backups, client installations of Hyperion products such as Essbase, Essbase Integration Services, Analyzer and Hyperion Reports on Windows environment and Linux, Shell scripting
• Security Management of user accounts with Roles and Privileges.
• Configure Access management using Celgene Active Directory controls.
• Possess a good knowledge of relational databases design and implementation, PL/SQL skills, RDBMS development knowledge and understanding of relational data marts.
• Excellent communication skills, team player with excellent analytical skills & problem-solving aptitude.
• Possess ability and willingness for learning new applications as needed

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Quality Assurance  [ 35017 ]

Job Category:  Quality Assurance   Listed on: 10/22/2019
Location:  Summit , NJ 07901

• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Must possess an independent mindset.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Work is self-directed.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Develops procedures.
• Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.
Responsibilities:
• Perform QA shop floor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shop floor documentation.
• Issue production batch records and product labels to Operations.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Able to effectively multi-task.

This position will provide 12 hour coverage including nights/ weekends.

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Project Manager  [ 35016 ]

Job Category:  Project Manager   Listed on: 10/22/2019
Location:  Summit , NJ 07901

Lead Engineer 3, Corporate Services
Reports To Title: Director ECCM or Sr Mgr, ECCM or Designee FLSA
Location: Summit, New Jersey

Position Overview:
The Lead Engineer 3 supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, applies expert knowledge and experience to design projects, goals and initiatives that result in new areas of opportunity and contribute to the strategic direction of the company. In addition to taking ownership of medium to large size projects, this subject matter expert independently plans programs to shape the strategic direction of the function and works with senior management to align the function with the overall strategic direction of the company. The incumbent applies leading edge technology and knowledge to provide expert guidance to multidisciplinary teams. This individual leverages constructive relationships across the organization to achieve goals on multi-disciplinary and cross-functional teams, and influences teams and stakeholders with fact-based, business value knowledge.

Essential Functions:
Initiates, manages and leads cross-functional/cross-site construction projects of medium to large scope and complexity at North American sites.
· Develops project scope of work with assistance from the customer, architect and engineers
· Assists with developing bid documents/RFQs for A/E and contractor scope of work
· Develops capital acquisition requisition documentation as required.
· Prepares purchase requisitions for project work and tracks them through final payment. Tracks and monitors project spending against capital budget.
· Ensures project timeline is met, anticipates next steps, and coordinates with impacted groups, as required
· Facilitates project meetings, directs engineering firms and consultants, provides field supervision and equipment inspection.
· Performs technical analysis / assessment of new and proposed technologies to balance performance, cost and maintainability.
· Monitors project for quality control and safety issues.
· Reviews all project documentation for compliance to Celgene standards. Prepares all project closeout documentation.
· Provides expert knowledge and direction as Engineering site representative during interactions with all cross functional groups, as required.
· Participates in the forecasting of project and capital budgets.
Provides Engineering technical support and leadership to Corporate Services and their customers.
· Identifies problems, leads troubleshooting and provides solutions for site infrastructure systems.
· Recommends and implements major changes to critical / ancillary systems, processes, and operating or maintenance activities in order to improve reliability and cost savings and safety enhancements, optimize labor utilization, and reduce carbon footprint.
· Provides oversight and direction to outside contracted service providers. Coordinates in-house and 3rd party contractor engineers, as required
· Supports corporate sustainability programs and initiatives through assistance with training and events. Incorporates energy saving and LEED initiatives into projects, when feasible. Supports site asset management and preventive maintenance programs
· Provides start up and commissioning documentation for all new equipment associated with projects
· Assists with creating new asset history information
· Initiates, guides and reviews the development and revision of required preventive maintenance procedures, work instructions and guidance documents for new equipment and processes. Promotes and provides excellent customer service and support.
· Regularly reviews, prioritizes, coordinates and promptly responds to customer project and support requests.
· Provides expert technical support and guidance on facilities/project-related issues and provides key decisions and recommendations to senior management on courses of action, as required.
· Maintains a positive relationship with all the members of the Engineering department and site customers while promoting a positive team environment. Promotes and maintains compliance with corporate, safety and regulatory policies.
· Maintains all required Corporate, Facilities and EHS training as required
· Champions adherence to and improvement of all safety procedures and hazard communication

Required Competencies-Knowledge, Skills, and Abilities:

Knowledge, Skills & Abilities:
· Strong understanding of building system design and construction in areas such as life-safety, lighting,
mechanical, electrical, and plumbing
· Significant knowledge of architectural design and construction
· Strong working knowledge of building codes, NEC, NFPA, OSHA and other basic safety training.
· Strong knowledge of FDA / cGXP requirements impacting Facilities systems, equipment and instrumentation within the pharmaceutical industry.
· Knowledge of critical utility systems such as HVAC, plant steam, compressed air, vacuum, RO/DI water, compressed gas and emergency power systems
· Strong knowledge and experience with the operation of pharmaceutical laboratory, facilities and manufacturing systems
· Experience at coordinating outside contractors and managing resources in support of system and equipment upgrade, installation, start-up and commissioning
· Ability to interact effectively with laboratory, QA, and Facilities groups as well as senior management
· Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. 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 with excellent 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 trade or assigned task. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation
· Exceptional leadership skills that encourages empowerment and ownership within the team and organization. Demonstrated ability to coach and mentor junior engineers as well as delegate tasks and responsibilities
· Ability to work independently with no supervision
· Intermediate estimating, budgeting and financial tracking skill
· Highly proficient in Microsoft Office Suite – Word, Excel and Outlook, and the innate ability to learn new software as required.

Competencies:
· Technical / Professional Knowledge
· Problem Solving / Troubleshooting
· Project Management
· Decision Making
· Action Oriented
· Multi-tasking
· Team Player / Building Relationships
· Active Listener
· Strategic Thinking

Education & Experience:
· BS degree in Engineering or closely related field or equivalent work
· Minimum 10 years of experience in project engineering management on a commercial or industrial site.
Prefer 5 years experience on an FDA regulated site.

Working Conditions:
Physical / Mental Demands:
· 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
· Minimal travel in North America

Environmental Conditions:
· Environment may include working in office or on construction site
· Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
· Ability to work safely in an environment with exposure to high temperature / pressure steam, and other
fluids, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas and
high voltage energ

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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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