CQV Engineer

Piper CompaniesPittsburgh, PA

30+ days ago

Job type

Full-time

Job description

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

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Engineer • Pittsburgh, PA