MEP, QA, Commissioning Professional

MEP, QA, & Commissioning Professionals Needed – Life Sciences Manufacturing Facility Construction

Location: Raleigh, NC

Employment Type: Full-Time

Industry: Life Sciences / Biopharmaceutical Manufacturing Construction

Overview:

We are seeking detail-oriented and disciplined MEP QA & Commissioning Professionals to support the quality assurance and commissioning efforts for a large-scale life sciences manufacturing facility construction project in Raleigh, NC. These positions are critical in ensuring that mechanical, electrical, plumbing, and process utility systems are installed, tested, and turned over in full compliance with design intent, regulatory standards, and Good Manufacturing Practice (GMP) requirements.

The ideal candidate has hands-on field experience with MEP and/or process utility systems, familiarity with commissioning and qualification (C&Q) processes, and a strong understanding of quality documentation, validation protocols, and system turnover requirements in regulated environments.

Key Responsibilities:

Quality Assurance & Documentation:

• Perform field inspections of mechanical, electrical, plumbing, and process utility installations to verify compliance with project drawings, specifications, and applicable codes and standards (cGMP, FDA, ISPE, NEC, ASME, etc.).
• Track and document QA/QC progress through inspection checklists, redlines, deviations, and punch list items.
• Support the review and validation of system installation records, test documentation, material traceability, and vendor certifications.
• Participate in quality audits and ensure all deviations or deficiencies are properly documented, investigated, and resolved in accordance with GMP requirements prior to system acceptance.

Commissioning & Qualification (C&Q) Support:

• Assist in the execution of commissioning and qualification activities, including pre-functional checks, functional testing, and support for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support the C&Q team by preparing and maintaining test protocols, commissioning/validation documentation, and field data collection tools.
• Verify equipment startup and system performance in alignment with approved protocols, SOPs, and acceptance criteria.
• Participate in commissioning and validation meetings, coordinate test readiness with contractors and validation teams, and support resolution of C&Q issues and deviations.

System Turnover & Closeout:

• Assist in the preparation and organization of system turnover packages, including as-built drawings, test results, calibration records, O&M manuals, SOPs, and training materials.
• Support validation of all required documentation to ensure compliance with regulatory and client requirements prior to final handover.
• Ensure that all QA/C&Q deliverables are properly tracked, logged, and submitted in accordance with project turnover and validation schedules.

Safety & Compliance:

• Adhere to all site-specific safety policies, as well as GMP and cleanroom protocols where applicable.
• Promote and support a culture of safety, quality, and regulatory compliance on the jobsite.

Qualifications:

• High school diploma or equivalent required; technical certification or associate degree in mechanical, electrical, construction, or life sciences disciplines preferred.
• At least 3–5 years of experience in MEP fieldwork, quality assurance, commissioning, or validation within life sciences, pharmaceutical, biotech, or regulated manufacturing environments.
• Working knowledge of mechanical and electrical systems such as HVAC (including cleanroom environments), chilled water, WFI (Water for Injection), clean steam, compressed gases, electrical distribution, and building management systems (BMS).
• Familiarity with commissioning and qualification standards and industry guidelines (ISPE Baseline Guides, ASTM E2500, GAMP 5, ASHRAE, NEBB, etc.).
• Experience using QA/C&Q software tools (e.g., Procore, BIM 360, Kneat, Blue Mountain, CxAlloy, or similar platforms).
• Strong organizational and communication skills, with attention to detail and documentation accuracy in regulated environments.
• Ability to interpret MEP drawings, P&IDs, process flow diagrams (PFDs), and control system architectures.
• Comfortable working on active construction sites and within controlled environments; must be able to lift, bend, climb, and access mechanical/electrical spaces as needed.