52 applicants
AbbVie · 4 days ago
Senior Engineer, Validation Commissioning
Branchburg, NJ
Full-time
Onsite
Mid, Senior Level
6+ years exp
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Responsibilities
Work with end-user and project engineer to develop User Requirements Specifications and Functional / Design Specifications for new or modified equipment, facilities, and utilities.
Support Factory Acceptance Testing in conjunction with Project Engineer to confirm unit is acceptable.
Identify risk controls, critical elements and traceability of equipment design based on FMEA or other risk assessment.
Develop and execute commissioning, qualification and validation test protocols to ensure that the unit functions according to specifications.
Perform minor troubleshooting of issues encountered during commissioning and documentation of unresolved issues.
Able to support broader aspects of projects at times including: project leadership, developing operational procedures, support training of maintenance/technical staff/operators on new equipment, reviewing new or modified product documentation to ensure compatibility with qualified equipment and implementing changes in equipment parameters or recipes.
Leads Execution of Risk Mngmnt. including, periodic review and update per the Validation Master Plan, interface with best practices, establishing team's work practices including overall program, ccRA. Understands risk management principles. Can find and review documentation. Understands controls, impact of change, trace controls, and can estimate ratings using appropriate scale. Timely. Demonstrated success in FMEA authorization/facilitation.
Qualification as QRM facilitator commensurate with responsibility.
May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
Qualification
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Required
Bachelor’s Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience.
Knowledge of quality/compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing required
Experience in the development of commissioning, qualification, validation and risk management deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
Ability to supervise junior or contract team members (prior supervisory experience preferred)
Ability to manage complex projects and multiple projects (5+) simultaneously
Preferred
A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceuticals, or similar industries (preferred)
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Company
AbbVie
AbbVie is a pharmaceutical company that discovers, develops, and markets medicines.
10,001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (155)
2022 (299)
2021 (194)
2020 (197)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-21IPO· nyse:ABBV
Leadership Team
Robert Michael
President and Chief Operating Officer
A
Azita Saleki Gerhardt
Senior Vice President, Operations
Recent News
2024-06-05
News is my Business
2024-06-03
Company data provided by crunchbase
