6242 - Upstream Principal CQV Engineer / Lead Validation Engineer

• 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

We are seeking a CQV Engineer with hands-on experience in upstream bioprocessing systems to support commissioning, qualification, and validation activities for biopharmaceutical manufacturing operations. This role will focus on upstream unit operations and process equipment, ensuring systems are designed, installed, tested, and qualified in accordance with cGMP and regulatory expectations.

The ideal candidate will bring strong experience across the CQV lifecycle, including authoring validation documentation, coordinating commissioning activities, supporting vendor testing, and ensuring systems achieve operational readiness. Experience with digital validation platforms such as Kneat is highly desirable.

This position requires someone who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

• Support commissioning, qualification, and validation (CQV) activities for upstream bioprocess equipment and systems.

• Author, review, and execute CQV lifecycle documentation including:

  • Commissioning test protocols

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Validation summary reports

• Ensure validation documentation aligns with cGMP requirements and regulatory expectations.

• Participate in system impact assessments, risk assessments, and validation planning activities.

• Provide technical support for upstream bioprocess unit operations, including systems such as:

  • Bioreactors / fermenters

  • Media and buffer preparation systems

  • Cell culture support equipment

  • Filtration and associated upstream utilities

• Support equipment startup and operational readiness for upstream process systems.

• Collaborate with engineering and operations teams to resolve technical issues during commissioning and qualification.

• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.

• Coordinate with equipment vendors and integrators to ensure proper system installation and functionality.

• Participate in equipment startup, troubleshooting, and performance verification.

• Work closely with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

• Ensure commissioning and validation activities remain aligned with project timelines and milestones.

• Assist with deviation resolution, change control, and documentation updates as required.

• Utilize electronic validation platforms (e.g., Kneat) to develop and execute validation documentation.

• Ensure documentation integrity, traceability, and compliance within digital validation systems

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical field

• Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments

• Hands-on experience with upstream bioprocess equipment and systems

• Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ, protocols, reports)

• Ability to work cross-functionally with engineering, automation, vendors, and quality teams

• Strong communication, documentation, and organizational skills

• Experience with digital validation platforms such as Kneat

• Experience supporting FAT/SAT, commissioning, and equipment startup

• Familiarity with risk-based validation approaches

• Prior experience in biologics or cell culture manufacturing environments

• Onsite job requirement in Holly Springs, NC