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

The Senior CQV Engineer is responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities with a strong focus on CIP (Clean-In-Place) systems supporting Drug Substance Manufacturing. This role will serve as a technical subject matter expert for CIP system qualification and cleaning validation, ensuring compliance with GMP, regulatory, and internal quality standards.

The ideal candidate brings hands‑on experience in CIP system design review, qualification execution, and cleaning validation strategy, and can work independently in a fast‑paced manufacturing environment while collaborating cross‑functionally with Engineering, Manufacturing, Quality, and Automation teams.

CQV & Validation Execution

• Lead and execute commissioning, qualification, and validation activities for CIP systems supporting Drug Substance manufacturing operations
• Author, review, and execute IQ, OQ, and PQ protocols for CIP equipment and associated utilities
• Perform cleaning validation activities for CIP systems, including development of validation strategies, protocols, sampling plans, and final reports
• Ensure CIP systems meet regulatory expectations for cleanability, reproducibility, and worst‑case conditions

CIP & Cleaning Validation

• Act as the SME for CIP systems, including spray devices, flow paths, cycle development, and acceptance criteria
• Support CIP cycle development and optimization in collaboration with Engineering and Manufacturing
• Perform risk assessments (e.g., FMEA, HACCP) to define validation scope and acceptance criteria
• Support residue, bioburden, and TOC sampling strategies as part of cleaning validation

Drug Substance Manufacturing Support

• Support Drug Substance manufacturing equipment and processes, ensuring validation activities align with process requirements and regulatory expectations
• Collaborate with Process Engineering and Manufacturing to ensure validated cleaning processes support operational efficiency and compliance
• Provide validation support during tech transfers, process changes, and new equipment installations

Compliance & Documentation

• Ensure all CQV and cleaning validation documentation complies with GMP, FDA, EMA, and ICH requirements
• Participate in deviation investigations, CAPAs, and change controls related to CIP systems and cleaning validation
• Support internal and external audits and regulatory inspections

Cross-Functional Collaboration

• Work closely with Engineering, Automation, Manufacturing, Quality Assurance, and Validation teams
• Provide guidance and mentoring to junior CQV engineers and validation resources as needed

• Bachelor’s degree in Engineering, Chemistry, Biology, or a related technical discipline (or equivalent experience)
• 6+ years of hands‑on experience in CQV / Validation within a GMP manufacturing environment
• Strong experience with CIP systems, including:
  • CIP system qualification (IQ/OQ/PQ)
  • Cleaning Validation in CIP
  • CIP cycle development and optimization
• Demonstrated experience supporting Drug Substance Manufacturing…