Lead Engineer

Lead Engineer, Equipment Commissioning and Qualification (ECQ) Delivery

Duties/Responsibilities
- Maintain qualified equipment systems in compliance with policies and procedures.
- Develop qualification protocols/reports; execute equipment qualifications/validation.
- Supervise vendors for qualification functions.
- Support development of equipment operational procedures and equipment validation.
- Create validation/qualification deliverables (Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, Summary Reports) and support Change Management.
- Manage equipment implementation projects (scheduling, site prep, installation, qualification, turnover).
- Support internal teams with operation, calibration, and preventive maintenance.
- Lead/oversee contract project teams to meet compliance and quality requirements; complete accurate qualification/validation documentation.
- Review/prioritize/respond to customer qualification/support requests; provide technical support and guidance.
- Ensure equipment/facilities/programs are maintained in compliance; may participate in deviation investigations as SME.

Qualifications / Required Skills
- Knowledge of cGMP, GXP, GAMP, SDLC; 21 CFR Part 11; computer systems validation; good documentation.
- Knowledge of pharmaceutical/manufacturing/lab systems; investigations/deviations/CAPA.
- Strong written/verbal communication; interpersonal skills; multitasking/organizational skills.
- Proficient in Microsoft Office; database systems; ability to learn new software.

Education & Experience
- BS Engineering/Science preferred (or equivalent experience).
- 4+ years GMP experience; 3+ years equipment/facility/utility qualification; 2+ years GMP project management.

Compensation & Benefits (as stated)
- Summit West (NJ, US): $88,450–$107,182.
- Health coverage; wellbeing support; 401(k) and insurance/disability; paid time off (details vary by employee type/location).