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6085 - Senior CQV Engineer / Senior Validation Engineer

Holly Springs, NC

Description

Verista’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

Job Summary:

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.

Senior CQV Engineer Responsibilities:

Utilities CQV Leadership

  • 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:

  • WFI (Water for Injection)
  • 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

Job Requirements:

  • 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 owner preferred 
  • Strong knowledge of GMP utilities systems and regulatory expectations
  • Proven ability to lead CQV execution independently
  • Strong understanding of IQ/OQ/PQ lifecycle
  • Excellent technical writing and documentation skills
  • Strong communication and cross-functional collaboration abilities
  • Detail-oriented with strong problem-solving skills
  • Experience supporting biotech, pharmaceutical, or cell & gene therapy facilities
  • Familiarity with automated utilities and building management systems (BMS)
  • Experience supporting regulatory inspections (FDA, EMA)
  • Experience on greenfield or large capital projects
  • Onsite support in plant, mechanical, and cleanroom environments
  • Onsite support required in Holly Springs, NC

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$70,491 - $108,980 USD

Benefits

Why Choose Verista?

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

For more information about our company, please visit us at Verista.com

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