Lead Engineer, CSV
Bristol Myers Squibb
5 days ago
Remote friendly (Summit, NJ)
United States
IT
Purpose of the Position
Lead CSV Engineer, Equipment Commissioning & Qualification (ECQ) supports configuring, implementing, and supporting manufacturing/laboratory equipment and computerized systems at multi-use sites.
Responsibilities / Essential Functions
- Investigate and resolve complex challenges including Deviations and CAPA.
- Support equipment qualification/validation; configure/document computerized systems to meet CFR 21 Part 11.
- Supervise vendors for qualification functions.
- Ensure accurate, complete, compliant qualification/validation documentation.
- Deliver lifecycle deliverables for equipment qualification and full CSV for single/multi-user computerized systems.
- Develop validation/qualification deliverables (Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls).
- Initiate/manage moderate-scope projects; manage varying-scope projects.
- Author quality procedures and training; deliver training and best practices.
- Support equipment implementation (scheduling, procurement, site prep, installation, qualification, turnover).
- Provide customer service/support; respond to qualification/validation requests; provide technical guidance.
- Ensure compliance for equipment/facilities/programs and act as departmental delegate/SME in audits.
Required Skills / Qualifications
- BS degree or equivalent experience.
- 5+ years in FDA-regulated industry.
- Strong MS Windows client/server knowledge.
- cGXP documentation practices; ISPE guidance; 21 CFR Part 11 compliance.
- SDLC principles; CSV deliverables authoring/execution.
- Ability to identify/document User & Functional Requirements.
- Knowledge of pharmaceutical lab/manufacturing systems.
- Strong communication, technical writing, and Microsoft Office skills.
- Ability to troubleshoot, multi-task, and manage concurrent assignments.
Compensation & Benefits (as stated)
- Summit West (NJ, US): $86,490–$104,803.
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, and 401(k) plus insurance/disability benefits.
- Paid time off (flexible time off/unlimited for US exempt; vacation/holidays for certain roles per location).
Lead CSV Engineer, Equipment Commissioning & Qualification (ECQ) supports configuring, implementing, and supporting manufacturing/laboratory equipment and computerized systems at multi-use sites.
Responsibilities / Essential Functions
- Investigate and resolve complex challenges including Deviations and CAPA.
- Support equipment qualification/validation; configure/document computerized systems to meet CFR 21 Part 11.
- Supervise vendors for qualification functions.
- Ensure accurate, complete, compliant qualification/validation documentation.
- Deliver lifecycle deliverables for equipment qualification and full CSV for single/multi-user computerized systems.
- Develop validation/qualification deliverables (Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls).
- Initiate/manage moderate-scope projects; manage varying-scope projects.
- Author quality procedures and training; deliver training and best practices.
- Support equipment implementation (scheduling, procurement, site prep, installation, qualification, turnover).
- Provide customer service/support; respond to qualification/validation requests; provide technical guidance.
- Ensure compliance for equipment/facilities/programs and act as departmental delegate/SME in audits.
Required Skills / Qualifications
- BS degree or equivalent experience.
- 5+ years in FDA-regulated industry.
- Strong MS Windows client/server knowledge.
- cGXP documentation practices; ISPE guidance; 21 CFR Part 11 compliance.
- SDLC principles; CSV deliverables authoring/execution.
- Ability to identify/document User & Functional Requirements.
- Knowledge of pharmaceutical lab/manufacturing systems.
- Strong communication, technical writing, and Microsoft Office skills.
- Ability to troubleshoot, multi-task, and manage concurrent assignments.
Compensation & Benefits (as stated)
- Summit West (NJ, US): $86,490–$104,803.
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, and 401(k) plus insurance/disability benefits.
- Paid time off (flexible time off/unlimited for US exempt; vacation/holidays for certain roles per location).