Description
The Senior Manager, Equipment Commissioning & Qualification (ECQ) Delivery supports successful operation of facility, laboratory, and business functions at multi-use sites by supervising commissioning/qualification and maintaining qualified/validated equipment systems.
Shift: Mon-Fri: 8AM-5PM
Responsibilities
- Directly manage equipment qualification and computerized system validation teams.
- Manage and allocate resources for validation of new/changed equipment and standalone/enterprise laboratory computerized systems.
- Define project technical strategy and needs across the project lifecycle.
- Oversee development/review/approval of SOPs, WPs, test protocols, validation deliverables, plans, and policies.
- Maintain commissioning/qualification procedures and ensure master plans comply with global policies and regulatory requirements.
- Provide input on change strategy, risk assessment, testing, and compliance gaps; ensure compliance with Facilities Services Qualification Master Plan.
- Oversee site requalification activities and manage budgets/resources.
- Create and deliver departmental metrics; identify improvement opportunities.
- Lead up to 50 staff (including 3 direct supervisors); interview/hire; set goals; conduct performance reviews; ensure training; manage EHS and policy compliance.
- Support customer request handling; provide technical guidance for qualification/validation issues.
- Act as departmental lead/SME in internal and regulatory audits.
Qualifications/Required Skills
- BS in Engineering or Science.
- 7+ years pharmaceutical application validation in a GMP environment.
- 7+ years managing personnel and projects.
- Expert knowledge of cGMP/GXP/GAMP/SDLC; 21 CFR Part 11; computer systems validation; documentation practices.
- Strong financial acumen; scheduling/execution/cost control; CAPA/deviations investigations.
- Strong written/verbal and interpersonal skills; strong presentation and Microsoft Office skills (Word/Excel/PowerPoint/Outlook) with database exposure.
- Working knowledge of scheduling/inventory systems (CMMS).
Compensation/Benefits (as stated)
- Summit West, NJ, US: $125,740 - $152,368; additional incentive cash/stock may be available.