6085 - Senior CQV Engineer / Senior Validation Engineer

Verista, Inc.•Holly Springs, NC

12h•Onsite

About The Position

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.

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)
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

Nice To Haves

Prior experience acting as a CQV Lead or system owner preferred

Responsibilities

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
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
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
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
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
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