Manager, Equipment & Engineering - 2904

Engineering Qualification, Manager

Responsibilities:
- Lead project management, commissioning, and qualification activities for facilities, utilities, and computer systems.
- Review manufacturer/blueprint specifications to identify critical parameters.
- Prepare Qualification Project Plans and protocols (IQ/OQ/PQ) and obtain approvals.
- Execute validation/qualification protocols per SOPs; verify acceptance criteria and record test data in compliance with cGMP.
- Prepare final reports; communicate timelines/status.
- Adhere to GMP, safety requirements, SOPs, and company policies.
- Conduct qualification reviews; manage CAPAs; review change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS as applicable.
- Prepare/update Site Validation Master Plans; develop and apply FMEAs, RCAs, and perform risk assessments.
- Demonstrate technical knowledge of computerized systems/equipment (preferably solid oral dosage manufacturing, facilities, and utilities).
- Support writing protocol deviations with root cause and corrective actions.

Qualifications (Education/Experience):
- Bachelor’s in Engineering (Chemical or Mechanical) required.
- Master’s in Engineering (Chemical or Mechanical) and Project Management preferred.
- 5–7 years’ experience in pharmaceutical or related manufacturing facilities.
- Preferred: qualification protocol/report experience for automated equipment/systems and computer systems.

Skills/Knowledge:
- Technical expertise in computerized systems, automation, and digital analytics; Power BI/Excel/Python.
- GMP, GAMP, CFR 21 Part 11; familiarity with regulatory bodies and risk management.
- Strong technical writing, deviation/CAPA management, and communication in English.

Benefits:
- Comprehensive health insurance; 401(k) match; Paid Time Off; company-paid life and disability insurance; additional listed benefits.

Application Instructions:
- Apply via Teva internal career site on Twist.