Senior CQV Engineer​/Senior Validation Engineer Holly Springs, NC

Holly Springs, NC

Versa’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision‑making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world‑class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

The Senior CQV Engineer – Utilities CQV Lead is responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities for critical GMP utilities systems supporting pharmaceutical and biopharmaceutical manufacturing operations. This role serves as the Utilities CQV Lead
, providing technical leadership and subject matter expertise across the full CQV lifecycle for multiple utility systems.

The ideal candidate has deep experience qualifying clean utilities and plant utilities
, is comfortable leading cross‑functional CQV efforts, and can ensure systems are designed, commissioned, qualified, and maintained in compliance with GMP and regulatory requirements
.

• Serve as the Utilities CQV Lead
  , owning CQV strategy, planning, and execution for assigned utility system
• Lead and coordinate CQV activities across Engineering, Automation, Manufacturing, and Quality teams
• Develop and manage CQV schedules, execution plans, and turnover packages for utilities systems

Utilities Systems CQV Execution

Lead CQV activities for the following critical utilities systems, including but not limited to:

• Clean Steam
• Glycol systems
• CIP chemical distribution systems
• Chilled Water
• Process Air
• NaOH distribution systems

Responsibilities include:

• Review of system design documentation, P&IDs, URSs, and specifications
• Authoring, reviewing, and executing commissioning, IQ, OQ, and PQ protocols
• Verification of system installation, operation, controls, alarms, and interlocks
• Supporting startup, commissioning, and system performance verification activities

Compliance & Validation Documentation

• Ensure all CQV documentation complies with GMP, FDA, EMA, and ICH requirements
• Author and review validation plans, protocols, reports, and traceability matrices
• Participate in deviation investigations, change controls, and CAPAs related to utilities systems
• Support internal audits and regulatory inspections related to utilities qualification

Technical Oversight & Risk Management

• Perform and support risk assessments (e.g.,
  FMEA, impact assessments
  ) to define validation scope and critical parameters
• Ensure utilities systems meet required quality attributes, reliability, and operational performance standards
• Collaborate with Automation and Engineering teams to verify proper system integration and control strategies

Cross‑Functional Collaboration

• Partner closely with Engineering, Automation, Quality Assurance, Manufacturing, and Facilities teams
• Provide CQV guidance during project execution, system modifications, and upgrades
• Mentor and support junior CQV engineers and validation resources as needed

• Bachelor’s degree in Engineering or a related technical discipline (or equivalent experience)
• 6+ years of CQV / Validation experience in a GMP manufacturing environment
• Demonstrated experience leading CQV activities for utilities systems, including:
  • WFI and Clean Steam
  • Process Air and Chilled Water
  • Glycol and chemical distribution systems (including NaOH and CIP chemicals
    )
• Prior experience acting as a CQV Lead or system…