Associate Director, Clean Validation

Fujifilm

Posted on : 23-08-2025

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1 Vacancy

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Job Location

Holly Springs, MS - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 23-08-2025

Job Description

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 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 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 FBNs 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:

Bachelors 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.

Masters 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.

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

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:

Director

Employment Type

Unclear

Company Industry

Department / Functional Area

Engineering

Key Skills

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About Company

Fujifilm

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Associate Director, Clean Validation

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Department / Functional Area

Key Skills

About Company

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