CQV Engineer

ZP GroupPittsburgh, PA
72d$100,000 - $120,000

About The Position

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.

Requirements

  • 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.

Responsibilities

  • 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.

Benefits

  • Medical
  • Dental
  • Vision
  • 401K
  • PTO
  • Sick Leave as required by law
  • Holidays

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Industry

Professional, Scientific, and Technical Services

Education Level

Bachelor's degree

Number of Employees

251-500 employees

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