CQV Engineer
About The Position
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are seeking an experienced Pharmaceutical Commissioning Engineer to join our team to work on a project with our San Francisco Bay Area pharmaceutical client. The ideal candidate will have a strong background in commissioning critical utility systems within a regulated pharmaceutical environment and a proven ability to adhere to client-specific quality standards. A fundamental understanding of ASTM E2500 will be considered a significant advantage, as it underpins risk-based approaches to design, qualification, and commissioning in compliance with industry best practices.
Requirements
- Bachelor’s degree in Engineering or related field (Mechanical, Chemical, or Process Engineering).
- Minimum [8] years of experience in pharmaceutical commissioning.
- Hands-on experience with critical utility systems listed above.
- Strong understanding of GMP, Pharmaceutical Quality Systems, and regulatory compliance.
- Proven ability to develop and implement QRM deliverables.
- Excellent communication and problem-solving skills.
Nice To Haves
- A Certified Commissioning Professional (CCP) is preferred.
- A fundamental understanding of ASTM E2500 will be considered a significant advantage, as it underpins risk-based approaches to design, qualification, and commissioning in compliance with industry best practices.
Responsibilities
- Lead and execute commissioning activities for the following systems: Non-Impact Systems Industrial Water System Sanitary Waste Distribution Refrigerated Water System Refrigerated Water Distribution Impact Systems WFI Generation Pretreatment skid AWFI generation skid Include tie-in to the existing WFI storage tank Autoclave Air Handler servicing Grade B & C Cleanrooms Clean Steam Distribution Clean Air Distribution
- Ensure compliance with the client’s Pharmaceutical Quality System throughout all phases of commissioning.
- Develop and maintain Quality Risk Management (QRM) deliverables, including risk assessments and mitigation strategies.
- Collaborate with cross-functional teams to ensure timely and successful project execution.
- Prepare and review commissioning documentation, protocols, and reports in alignment with GMP and regulatory requirements.
Benefits
- VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment.
- We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
51-100 employees
