Commissioning Engineer

1 week ago

Lebanon IN United States Brooksource Full time

Job Title: Commissioning and Qualification Engineer

Location: Lebanon (pharmaceutical manufacturing site)

Type: 2-3 year contract through Brooksource Engineering Services

Job Overview:

The Commissioning and Qualification Engineer is responsible for equipment verification, qualification, and compliance verification during the commissioning of a major pharmaceutical start-up project. This role requires in-depth knowledge of pharmaceutical equipment standards, validation processes, and quality documentation. The ideal candidate will have a background in engineering or validation within a regulated environment.

Key Responsibilities:

  • Attend Factory Acceptance Tests (FATs) for critical equipment, supporting execution and verifying that equipment meets specifications and user requirements.
  • Conduct comprehensive walkdowns of mechanically complete systems to ensure compliance with design and user requirements, identifying technical and operational issues.
  • Document and communicate installation defects, create punch lists, and oversee defect rectification with General Contractors and subcontractors.
  • Review contractor turnover binders and verify construction quality documents (e.g., pressure test, weld inspection, material certification) for completion and accuracy.
  • Perform Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ) for critical systems, ensuring all elements meet design specifications and GMP compliance.
  • Raise and manage change controls and deviations as needed, coordinating with Subject Matter Experts and reviewers to ensure quality standards.
  • Verify installation compliance, including drawing updates, tagging, material verification, and adherence to safety and operational standards.
  • Witness and document critical construction and operational testing, including pressure testing, calibration, loop checks, and system energizations.

Qualifications:

  • Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or similar field) or Life Sciences.
  • Minimum of 5-7 years in commissioning, qualification, or validation roles within the pharmaceutical, biotech, or medical device industry.
  • Strong understanding of GMP, IQ/OQ/PQ processes, and regulatory standards (e.g., FDA, EU) in the life sciences sector.
  • Familiarity with turnover packages, change control, and CAPA processes, as well as technical drawings and redlining.
  • Ability to collaborate with contractors, vendors, and cross-functional teams, effectively communicating technical issues and solutions.

Nice-to-Haves:

  • Advanced certifications such as ASQ Certified Quality Engineer (CQE), Certified Pharmaceutical GMP Professional (CPGP), or similar.
  • Direct experience in pharmaceutical start-up projects, especially in sterile manufacturing, cleanroom environments, or biologics.
  • Familiarity with validation software (e.g., ValGenesis, Kneat) or digital tools for commissioning and qualification tracking.
  • Experience leading small teams in validation or commissioning tasks, with strong organizational and problem-solving abilities.


Eight Eleven Group (Brooksource) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

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