Senior Engineer, Cleaning Validation

Position Overview

The Sr CQV Engineer 1 leads the commissioning and qualification of equipment and systems of assigned area for the site. This role performs and leads the CQV team through the validation lifecycle investigation of deviations and root cause analyses and establishes standard operating procedures and other documents. This role collaborates with internal and external stakeholders to ensure strategies equipment and systems incorporate global standards and
align and comply with regulatory requirements and quality standards. Additionally this role provides training and guidance to junior engineers to ensure successful integration of CQV activities into site projects.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll Do

Acts as CQV Technical Lead for process support equipment to establish validation strategies develop validation procedures that align with FDBs
Large Scale Biologics platform operating principles and regulatory requirements
Provides guidance and leads the management of validation lifecycle for responsible areas for process support equipment and warehouse during
Installation Verification (IV) Operational Verification (OV) Installation & Operational Qualification (IOQ) Performance Qualification (PQ) through
Good Manufacturing Practices (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 FDBs 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 (e.g. Manufacturing Process Science Automation Supply Chain and Quality) to
ensure FDB validation requirements are met
Collaborates cross-functionally to ensure successful integration of CQV activities into projects
Establishes Validation standard operating procedures (SOPs) Validation Project Plan (VPP) and Validation Master Plan (VMP) to ensure full cGMP
compliance by operations launch
Liaises with CQV Document Generation Lead to generate and approve DQ Design Reviews SLIA Test Matrices Risk Assessments QA Vendor
Assessments FAT SAT CTP and IOQ Protocols
Leads the investigation of qualification deviations or discrepancies utilizing problem solving and root cause analysis (RCA) to properly identify root
causes and develop remediation plans (e.g. corrective and preventive action (CAPAs))
Performs change control validation assessments to determine risk-based qualification requirements for new systems and changes to existing
qualified systems
Conducts impact and risk assessments and identifies risks and develops and leads the implementation of mitigation strategies
Provides guidance and training to junior engineers for all CQV-related activities as needed
Other duties as assigned

Minimum Requirements:

Bachelors degree in Engineering
8 years of experience in validation activities in facilities
commissioning and systems qualifications
Experience with cGMP or working in another highly regulated
industry

Preferred Requirements:

Masters degree in Engineering with 6 years of experience in
validation activities in facilities commissioning and system
qualifications

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Senior IC