CQV Engineer

Piper Companies is currently seeking a highly skilled and motivated CQV Engineer to join our team in Pittsburgh, PA, supporting a greenfield biologics manufacturing facility. This role is ideal for professionals with a strong background in Commissioning, Qualification, and Validation (CQV) within the biopharmaceutical industry, particularly those with hands-on experience in greenfield site start-ups.

Responsibilities for the CQV Engineer:

• Lead and execute CQV activities for facility, utility, and process equipment in a biologics manufacturing environment.
• Develop and implement IQ/OQ/PQ protocols in compliance with GMP, FDA, and ICH guidelines.
• Collaborate with cross-functional teams including engineering, quality, and operations to ensure timely project delivery.
• Support design reviews, FAT/SAT, and risk assessments (e.g., FMEA).
• Manage and resolve deviations, CAPAs, and change controls related to CQV scope.
• Maintain detailed documentation and ensure audit readiness.

Qualifications for the CQV Engineer:

• Bachelor's degree in Engineering, Life Sciences, or related field.
• Minimum 6 years of CQV experience in the biologics/pharmaceutical industry.
• Proven experience with greenfield or large-scale capital projects.
• Strong knowledge of GMP regulations, validation lifecycle, and bioprocessing equipment.
• Excellent communication, organizational, and problem-solving skills.

Compensation for the CQV Engineer:

• Salary Range: $100,000-$120,000
• Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays