Commissioning & Qualification (C&Q) Engineer

Position: Commissioning & Qualification (C&Q) Engineer

Location: Vacaville, CA (Onsite)

Length: 6+ Month Contract

Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available

Job Description:

The C&Q Engineer will be responsible for field execution and/or oversight of commissioning and qualification activities performed by others. Protocol execution will be managed in Kneat, except for engineering frontline startup/shakedown activities and vendor protocols, which will be executed using digital or scanned documentation for upload to Kneat and digital approval. All protocol execution will follow Good Engineering Practices (GEP), Good Documentation Practices (GDP), and applicable company standard operating procedures.

Essential Duties and Responsibilities:

• Execute or oversee Factory Acceptance Testing (FAT).
• Execute or oversee Site Acceptance Testing (SAT).
• Support engineering frontline startup and shakedown activities.
• Support debugging and commissioning activities.
• Perform Installation Verification and Turnover Package (TOP) activities.
• Execute Installation Qualification (IQ).
• Execute CIP recipe runs.
• Execute SIP recipe runs.
• Coordinate sampling for WFI, clean steam, clean air, process gases, and cleanroom environmental monitoring.
• Support SIP biological indicator (BI) testing.
• Execute or oversee automation qualifications.
• Execute or oversee operational qualifications.
• Execute or oversee performance qualifications.
• Ensure documentation is completed accurately and in accordance with GEP, GDP, and applicable SOP requirements.
• Manage protocol documentation and approvals through Kneat as required.

Qualifications:

• Experience with commissioning and qualification activities in a regulated manufacturing or life sciences environment.
• Familiarity with GEP, GDP, SOP-driven execution, and controlled documentation practices.
• Experience with Kneat or a comparable electronic commissioning and qualification platform preferred.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Come see why DPC has achieved:

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
• Voted ‘Best Staffing Firm to Temp/Contract For’ 8 consecutive years in a row by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!

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Job # 19091