SRG, the leader in the Life Sciences human capital industry, is looking for a CQV Utilities Engineer to join our client's Biotech team in Pennsylvania. This is an upcoming role and we are looking to connect with potentially interested consultants.

Duration: 6-12+ months

Schedule: Full-Time, Onsite

Industry: Cell & Gene Therapy

MUST HAVES:

• Bachelor's degree in engineering, Life Sciences, or related discipline.
• 5-7 years of CQV experience in the pharmaceutical or biotech industry with facility and utility commissioning and qualification.
• Utilities (HVAC, water systems) validation
• Strong background in CQV green and brown field facilities, CSV/CSA, CMMS qualification, and GMP systems
• Hands-on experience using Kneat for electronic validation lifecycle management (preferred)

JOB RESPONSIBILITIES:

• CQV efforts for facility, utilities, computerized systems, and CMMS qualification activities, with a focus on regulatory compliance and execution excellence
• Plan, develop, and execute commissioning and qualification activities for facility systems, GMP utilities, and computerized systems.
• Perform CSV and CSA activities in alignment with GAMP 5 and risk-based validation principles.
• Lead or support qualification of CMMS (Computerized Maintenance Management System) BMRAM R.3/4 platforms in a GMP setting.
• Prepare and review CQV documentation including URS, Risk Assessments, Protocols (IQ/OQ/PQ), and Final Reports.
• Collaborate with QA, IT, Digital Technologies, and Facility & Engineering teams to ensure timely delivery of CQV milestones.
• Ensure compliance with applicable regulatory guidelines for sterile operations, ATMPs, including 21 CFR 210, 211, 610, Part 11, EudraLex Vol. 4 Part 2 Annex 1, 11, 15, Part IV (ATMPs) and relevant data integrity requirements.
• Utilize Kneat for documentation, routing, execution, and traceability of validation lifecycle documents, where applicable.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.