Associate Director, Clean Validation
Company: Fujifilm
Location: Holly Springs
Posted on: November 29, 2025
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Job Description:
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.” What
Youll Do • 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 Minimum 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. OR • 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 Preferred
Requirements: • 8 years of people management & leadership
experience • Experience in large scale life science company. •
Experience in green field project Physical and Work Environment
Requirements: • Will work in environment which may necessitate
respiratory protection. • May work in Mechanical/Production spaces
that may require hearing protection and enrollment in a hearing
conservation program. • Ability to discern audible cues. • Ability
to inspect or perform a task with 20/20 corrected vision, visual
acuity, including distinguishing color. • Ability to ascend or
descend ladders, scaffolding, ramps, etc. • Ability to stand for
prolonged periods of time up to 240 minutes. • Ability to sit for
prolonged periods of time up to 240 minutes. • Ability to conduct
activities using repetitive motions that include wrists, hands
and/or fingers. • Will work in warm/cold environments. • Will work
in outdoor elements such as precipitation and wind. • Will work in
small and/or enclosed spaces.
Keywords: Fujifilm, Cary , Associate Director, Clean Validation, Engineering , Holly Springs, North Carolina
