Lead CQV Specialist

Job Title: Lead CQV Specialist Location: Raleigh-Durham-Chapel Hill, NC (Onsite at client facility) Job Type: Contract

Job Description: We are seeking an experienced Lead CQV Specialist to join our growing team. The successful candidate will work onsite with our client, supporting commissioning, qualification, and validation (CQV) of upstream and downstream bioprocess systems/equipment within the biopharmaceutical industry. This role requires leadership skills to mentor and guide intermediate/junior specialists.

Responsibilities

• Provide technical guidance for commissioning, qualification, and start-up of cGMP process equipment, utilities, and facilities.

• Develop qualification deliverables (DQ, FAT, SAT, IQ, OQ, PQ) and perform field execution of protocols.

• Support development of Project Validation Plans (PVPs).

• Lead qualification processes to ensure project specifications are met and timelines achieved.

• Ensure compliance with regulatory requirements and industry best practices (process equipment, clean utilities, automation, laboratory systems, facilities).

• Coordinate meetings with cross-functional departments and facilitate project decisions.

• Participate in design reviews, FAT/SAT execution, and vendor meetings (occasional travel).

• Supervise contractors during critical testing phases.

• Support client management, project scheduling, budgeting, and business development as needed.

• Mentor/lead junior and intermediate validation specialists.

• Comply with client site safety rules and mandatory requirements (including vaccination policies where applicable).

Qualifications

• 12+ years’ experience in commissioning, qualification, and validation in pharma/biotech industry.

• Hands-on experience with C&Q of biotech process equipment (e.g., fermentation, bioreactors, chromatography, TFF, CIP systems, buffer systems, clean utilities).

• Experience with clean utilities and ISO clean rooms qualification.

• Knowledge of Risk-Based CQV approaches (ASTM E-2500, ISPE ICQ).

• Experience with process control systems (PCS, SCADA, Historians) and building automation systems (asset).

• Familiar with validation documentation (URS, DQ, RTM, Risk Assessments, CPP, VPP, FAT, SAT, IOQ).

• Experience in cleaning validation, thermal validation, mixing studies, process validation, or CSV is an asset.

• Strong leadership/mentorship skills to guide teams and junior staff.

• Degree in Mechanical, Electrical, Chemical Engineering, Life Sciences, or related field.

• Ability to manage multiple projects in a fast-paced environment.

• Strong multitasking and problem-solving skills.

• Occasional travel may be required.

• Work Environment:

• Onsite at client facilities.

• May require extended hours during commissioning/validation phases.

• Requires PPE at construction/installation sites.

• If you’re an experienced CQV professional looking to take on a leadership role in the Raleigh-Durham-Chapel Hill area , we’d love to connect with you.