CQV Engineer

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.Key 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.

Qualifications:

• Bachelor’s degree in Engineering or related field (Mechanical, Chemical, or Process Engineering).
  • A Certified Commissioning Professional (CCP) is preferred.
• 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.

SALARY RANGE FOR THIS POSITION IS $90,000 - $120,000

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org

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