We are seeking a CQV Start-Up / Commissioning Project Manager for assignment in Conshohocken, Pennsylvania. The selected candidate will work for a global engineering firm providing commissioning and start-up services to clients in the Life Sciences industry
Hours are Monday - Friday, 8:00am - 4:00pm
** This position requires Black Utilities and HVAC start-up experience **
Responsibilities- Serve a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers
- Client facing with an emphasis on ensuring commissioning project deliverables meet schedule, cost, scope, quality and safety
- Responsible for the development of start-up and commissioning plans, commissioning documentation and execution of these documents for a variety of facilities, utility systems and equipment
- Accountable for oversight, coordination and execution of the start-up, energization, commissioning and visual inspection of facilities, black and clean utility systems, instrumentation, HVAC and production equipment
- Start-up equipment in a safe and effective manner
- Facilitate meetings for the start-up team
- Maintain engineering change control logs
- Coordination of OEM service technicians and construction management firm as needed
Qualifications- Bachelors Degree in Mechanical, Electrical or Chemical Engineering
- 5 - 15 years of start-up and commissioning experience in the life sciences industry
- Black Utilities and HVAC start-up experience is required
- Understanding of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs)
- Proposal development experience is a plus
- Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA Regulations is a plus
- Knowledge of ISPE Guidelines is a plus
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