Downstream CQV Manager

Job Title: Downstream CQV Manager Location: Holly Springs, NC

Experience: 7 - 9 Years

(Local candidates preferred; relocation or US domestic travelers considered)

About the Role

We’re looking for an experienced Downstream Commissioning, Qualification, and Validation (CQV) Manager with strong expertise in downstream bioprocessing. This is a hands-on leadership role focused on driving CQV activities for complex biopharmaceutical manufacturing processes. If you have deep technical knowledge of filtration, chromatography, and single-use systems , and enjoy solving problems in real time, this role could be a great fit.

Key Responsibilities

Lead and coordinate all downstream CQV activities in compliance with GMP, regulatory, and internal standards.

Oversee commissioning and qualification of downstream equipment (filtration, chromatography, single-use systems).

Develop and execute qualification protocols (IQ, OQ, PQ) for downstream processes.

Troubleshoot equipment and process issues during commissioning and qualification.

Partner with process engineering, validation, and manufacturing teams to align deliverables.

Support FAT/SAT, start-up, and process validation activities with technical expertise.

Maintain complete and accurate documentation throughout the CQV lifecycle.

Deliver CQV milestones on time to support project schedules.

Perform other related duties as assigned.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field (advanced degree preferred).

• 7+ years of CQV experience in the biopharmaceutical industry with focus on downstream processing.

• Proven hands-on expertise with filtration, chromatography, and single-use equipment.

• Strong troubleshooting and problem-solving skills.

• Experience leading CQV projects and cross-functional teams.

• Deep understanding of GMP requirements and qualification protocols.

• Excellent organizational and communication skills.

• Local to Holly Springs, NC preferred; will consider relocation or domestic travelers.

• Prior experience with greenfield or large-scale start-up projects is highly desirable.

• Familiarity with electronic quality management systems (eQMS).

• Must have legal authorization to work in the US.