Senior CQV Engineer - Biologics Validation Leader

FUJIFILM; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior CQV Engineer to lead commissioning and qualification of process support equipment and systems, ensuring GMP compliance and alignment with global standards. The role guides the CQV team through IV, OV, IOQ and PQ activities while collaborating with internal and external stakeholders.

You will develop SOPs, plans, risk assessments, and validation documentation, train junior engineers, and support audits and regulatory submissions while

Qualifications

• Bachelors degree in Engineering; 8+ years in validation activities for facilities, commissioning, and systems qualifications.
• Experience with cGMP or highly regulated industries.
• Masters degree preferred for Senior Engineer II with additional years of experience.

Responsibilities

• Lead CQV technical strategy for process equipment and validate through IV/OV/IOQ/PQ.
• Manage validation lifecycle and CAPA investigations.
• Coordinate with Manufacturing, Process Science, Automation, Supply Chain and Quality for compliance.
• Develop SOPs, VPP, and VMP ensuring full cGMP compliance at site launches.
• Provide training to junior engineers in CQV activities.

Skills

Effective communication

Presentation skills

MS Office

Regulatory knowledge

Cross-functional collaboration

Education

Bachelors degree in Engineering

Masters degree in Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior CQV Engineer to lead commissioning and qualification of process support equipment and systems, ensuring GMP compliance and alignment with global standards. The role guides the CQV team through IV, OV, IOQ and PQ activities while collaborating with internal and external stakeholders.

You will develop SOPs, plans, risk assessments, and validation documentation, train junior engineers, and support audits and regulatory submissions while