Associate Director, Clean Validation

Fujifilm•Holly Springs, NC

About The Position

Position Overview The Associate Director, Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well as ASTM E2500 guidelines. This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment with Good Engineering Practices (GEP) and Risk-based Validation approach. This role exists to guarantee the integrity and compliance of production systems and to mitigate risks associated with the therapeutic product lifecycle. The Associate Director collaborates with cross-functional teams to drive continuous improvement and optimize CV practices. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re 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 we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers Job Description What You'll Do

Requirements

Bachelor’s degree in engineering, Life Sciences, or a related field with 11+ years of experience in commissioning, qualification, and validation in the pharmaceutical or biotechnology industry.
Master’s degree in engineering, Life Sciences, or a related field with 9+ years of experience in commissioning, qualification, and validation in the pharmaceutical or biotechnology industry.
Proven Leadership Experience
Experience with US and international regulatory standards and ICH guidelines especially with regards to data integrity
Experience with regulatory submissions including cleaning validation sections of CTDs and NDAs
Experience of Electronic Validation systems such as KNEAT or similar
Experience of Lives Temperature Mapping systems or similar

Nice To Haves

8+ years of people management & leadership experience
Experience in large scale life science company.
Experience in green field project

Responsibilities

Acts as CQV Technical Lead for the site to establish Cleaning Validation (CV) strategies, and develop CV procedures to align with FUJIFILM Biotechnologies (FB) Large Scale Biologics platform operating principles and regulatory requirements
Ensures compliance with 21 CFR Parts 11, 210, and 211, ASTM E2500, ISPE Baseline Guides, and industry best practices
Provides leadership for the risk-based verification approach, ensuring CQV programs focus on critical aspects affecting product quality and patient safety
Collaborates with Quality, Engineering, Manufacturing, and Regulatory teams to ensure alignment on validation strategies and readiness for regulatory inspections
Participates and represents CQV in new client or molecule business proposal reviews and assists with onboarding of new molecules at the site level
Leads presentations of FBN’s CV Lifecycle program during internal and external audits
Designs, implements, and oversees comprehensive cleaning validation program for multi-product manufacturing suites including Drug Substance, Drug Product, and Weigh and Dispense (Warehouse) areas
Leads the development of risk-based cleaning validation approaches incorporating Quality by Design (QbD) principles
Provides technical leadership in cleaning method development, validation protocol design, and acceptance criteria establishment (MSC/MACO)
Leads investigations of CV deviations and implement corrective and preventive actions (CAPA)
Establishes Validation standard operating procedures (SOPs), Validation Project Plan (VPP), Validation Master Plan (VMP) to ensure full CGMP compliance by operations launch
Ensures the integration of process validation (PV), CV, and computerized system validation (CSV) into the overall CQV strategy.
Develops the strategy for periodic reviews and requalification of equipment, utilities, facilities to ensure CGMP compliance
Oversees deviation investigations, change control evaluations, and continuous improvements within the validation framework, ensuring on-time closure and completion of compliance initiatives
Provides CQV leadership for capital projects, ensuring timely execution of CV activities within budget and schedule constraints
Provides technical support and leads team of external validation engineers through commissioning, qualification and validation of large-scale biologics facilities and equipment
Manages CQV resource allocation, including internal teams and external CQV contractors
Drives continuous improvement initiatives to optimize CQV processes and reduce validation cycle times
Ensures proper documentation control and approval processes for all validation deliverables
Manages, coaches and mentors’ direct reports and team members to foster professional development and growth
Partners with HR, Talent Acquisition, and various stakeholders to recruit talent, create retention strategies, and handle employee concerns
Addresses employee concerns and partners with HR for resolution, as needed
Evaluates team performance, addresses gaps, and implements measures to improve productivity and engagement
Performs other duties, as assigned