Senior CQV Engineer: Process & Clean Utilities Lead

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

Job summary

FUJIFILM Biotechnologies is seeking a Senior CQV Engineer to lead commissioning and qualification efforts for equipment and systems at the Holly Springs site. The role guides the CQV team through the validation lifecycle, investigations of deviations, and root cause analyses to ensure compliance with global standards and regulatory quality requirements.

The position also involves training and mentoring junior engineers to ensure successful integration of CQV activities into site projects and

Qualifications

• Effective communication and presentation skills are essential.
• Proficient in Microsoft Office applications.
• Knowledge of ISPE, PDA, FDA, ICH, ISO and EU guidelines for GMP validation.

Responsibilities

• Acts as CQV Technical Lead for process support equipment to establish validation strategies.
• Provides guidance and leads the management of validation lifecycle for responsible areas for process support equipment and warehouse during IV, OV, IOQ, PQ through GMP release to decommissioning.
• Provides technical support and leads external validation engineers through commissioning, qualification and validation of Large-Scale Biologics facilities and equipment.
• Participates with FUJIFILM Biotechnologies cross-network to inform and influence strategic management of validation programs, and working knowledge to incorporate global standards at the site level.
• Liaises and collaborates with key stakeholders and support groups to ensure FDB validation requirements are met.
• Collaborates cross-functionally to ensure successful integration of CQV activities into projects.
• Establishes Validation SOPs, Validation Project Plan (VPP), and Validation Master Plan (VMP) to ensure full cGMP compliance by operations launch.

Skills

Effective communication

Present information

MS Office

Regulatory guidelines knowledge

Education

Bachelor's degree in Engineering

Job description

FUJIFILM Biotechnologies is seeking a Senior CQV Engineer to lead commissioning and qualification efforts for equipment and systems at the Holly Springs site. The role guides the CQV team through the validation lifecycle, investigations of deviations, and root cause analyses to ensure compliance with global standards and regulatory quality requirements.

The position also involves training and mentoring junior engineers to ensure successful integration of CQV activities into site projects and