CQV Engineer

Piper Companies is seeking a CQV Engineer to join a growing leader in the pharmaceutical/biotechnology space for an onsite contract position for 6 months in Pittsburgh, PA. The CQV Engineer will lead and support the commissioning, qualification, and validation of GMP facilities, utilities, and computerized systems to ensure compliance with regulatory standards and successful project execution.

Responsibilities of the CQV Engineer include:

• Plan, execute, and document commissioning and qualification activities for GMP utilities, facility systems, and computerized systems in compliance with regulatory standards.
• Perform CSV and CSA tasks following GAMP 5 and risk-based validation approaches, including qualification of CMMS platforms such as BMRAM R.3/4.
• Develop and review validation lifecycle documents including URS, risk assessments, IQ/OQ/PQ protocols, and final reports.
• Collaborate cross-functionally with QA, IT, Digital Technologies, and Engineering teams to ensure timely and compliant CQV deliverables.
• Utilize electronic validation tools (e.g., Kneat) to manage documentation, execution, and traceability of CQV activities.

Qualifications for the CQV Engineer include:

• 5–8 years of experience in Commissioning, Qualification, and Validation (CQV) within the pharmaceutical or biotechnology industry.
• Proficient in Computer System Validation (CSV) and Computer Software Assurance (CSA) methodologies for GxP-compliant systems and GMP infrastructure.
• Demonstrated expertise in commissioning and qualifying facilities, utilities, and CMMS platforms in regulated environments.
• Strong command of validation lifecycle documentation, regulatory standards, and technical writing best practices.
• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.

 Compensation for the CQV Engineer:

• Salary Range: $75-$85/hour (USD)
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

This job opens for applications on 7/3. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: CQV Engineer, Commissioning Qualification and Validation, Biopharmaceutical Process Equipment, Upstream and Downstream Systems, CIP Systems, GMP Compliance, IQ OQ PQ Protocols, Risk Assessment, Team Leadership, Process Validation, Operational Excellence, Technical Expertise, Mentorship, Regulatory Standards.

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