CQV Engineer - Blackfield Associates : Job Details

Blackfield Associates are currently partnered with a large biologics manufacturer to support their search for a CQV Engineer to join their project based in Pittsburgh, PA on an initial 6-month contract.

Key Responsibilities:

• Plan and execute commissioning and qualification for facility systems, GMP utilities, and computerized systems.
• Perform CSV and CSA activities in line with GAMP 5 and risk-based validation principles.
• Lead or support qualification of CMMS platforms in GMP environments.
• Prepare and review validation documentation (URS, Risk Assessments, IQ/OQ/PQ Protocols, Final Reports).
• Collaborate with QA, IT, and Engineering teams to meet CQV milestones.
• Ensure compliance with regulatory standards including 21 CFR Parts 11, 210, 211, 610; EudraLex Vol. 4 Annexes 1, 11, 15; and ATMP guidelines.
• Use Kneat for managing validation lifecycle documentation and traceability.

Required Experience & Skills:

• Bachelor's degree in Engineering, Life Sciences, or related field.
• Sufficent years of CQV experience in pharmaceutical or biotech industries.
• Proficiency in CSV/CSA for GxP systems and GMP infrastructure.
• Hands-on experience with facility and utility commissioning and qualification.
• Experience qualifying CMMS in regulated environments.
• Strong understanding of validation documentation and regulatory compliance.
• Excellent communication and technical writing skills.