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Head of Global Single Use Validation

Employer
FUJIFILM Diosynth Biotechnologies
Location
Research Triangle Park, NC
Start date
Sep 26, 2022

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Discipline
Information Technology, Applications/Technical Support
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC
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Job Details

The Head of Global Single Use (SU) Validation is responsible for designing, maintaining, and continually improving the validation systems in line with current standards. This Head will oversee all Validation aspects of the Single Use Standard across FDB. They will provide leadership, personnel development and oversite of the Company's validation teams and systems for the standard single use facilities.

External US

The Head of Global Single Use (SU) Validation is responsible for designing, maintaining, and continually improving the validation systems in line with current standards. This Head will oversee all Validation aspects of the Single Use Standard across FDB. They will provide leadership, personnel development and oversite of the Company's validation teams and systems for the standard single use facilities.

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.

As we grow our community, our capacity, and capabilities significantly in the next year, we're looking for passionate people to join our global team. This is a global position that will support all sites (Denmark, United Kingdom, Texas and North Carolina). This position is based in the United States.

Essential Functions:

  • Design a Risk Based Validation approach for the evolved SU Standard: covering facility, equipment, consumables, intra- and inter- campus operation, QC, warehouse, Computer Systems, Data Integrity.
  • Responsible for strategy and master planning
  • Standards-based facilities shall be carved out from local systems and shall align globally—FDBU, FDBK and FDBT—or any other site that adds a SU standard facility.
  • Build a group to support ongoing approved A3's, future A3's, and future change management and alignment activities.
  • Build training and develop local leads will full knowledge of both philosophy of approach and practical implementation.
  • Build department to have SME's who cover all required sub-fields within Validation. Provide expert guidance and to the validation team in establishing policies, procedures and strategies that are consistent with CGMP, International guidance and the Company's Quality Programs.
  • Design and implement facilities and equipment qualification and validation protocols.
  • Develop and implement a revalidation schedule for qualified systems.
  • Design and implement Process Validation Plans that include Facility, Process and Cleaning in conjunction with process science.
  • Create a lean, risk-based approach to include family approach, leveraging of commissioning activities, out of place qualification, form based-qualification, etc.
  • Collaborate with Head of SU Roadmap to align of validation standards and approach for novel SU equipment.
  • Develop lean system for identifying, documenting and communication risk and risk controls to operational functions.
  • Support audits at sites covered in this effort.
  • Work closely with QA lead for global standard to align expectations and compliance with a lean, risk-based approach.
  • Complete all validation documentation in a timely and compliant manner including participation in the review of validation documentation to obtain QA sign-off.
  • Focus on continuous improvement — ability to evaluate systems to improve system functionality and efficiency.
  • Align with operations to establish lean new product, process, and equipment introduction to the network.
  • All other duties as assigned.

Required Skills & Abilities:

  • Extensive knowledge of modern risk-based validation approaches.
  • Knowledge of executing validation of closed systems.
  • Relevant experience at the executive level in a matrix environment.
  • Demonstrated affinity for lean approach, establishment of predictive metrics.
  • Requires strong commitment to accuracy, timeliness, and functional organization.
  • Hands on experience in building teams to execute Commissioning, Qualification and Validation activities (CQV) to include:
    • New facility CQV activities and scheduling o Process o Cleaning
    • Good working knowledge of cGMP and regulatory standards for validation.
    • High in openness to and integrational skills to innovate in a constrained environment.
    • Experience in presenting to clients, competent authorities, and board-level executives.
    • Experience in writing and reviewing SOPs and protocols for accuracy, traceability, and compliance.
    • Experience in performing and leading validation studies within the pharmaceutical and biotechnology industry.
    • Proficiency with Microsoft Office products, including Word, Excel, Outlook, PowerPoint and other analytical applications
    • Excellent written and oral communication skills.
    • Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
  • Position may be locally or remotely based with ability to travel extensively to Europe and multiple sites in the US. Travel to other global regions may be required at future.

Qualifications:

  • Undergraduate degree (Engineering, Chemical Engineering or Mechanical Engineering, Biochemistry, Molecular Biology, Microbiology, Chemistry, etc.).
  • At least 20 years of experience in Validation in a GMP environment.
  • Lean training and experience with risk-based approach.
  • Exposure to many difference quality systems with global reach.
  • At least 3 years of executive experience.

Preferred Qualifications:

  • Experience in new facility construction, commissioning, qualification, and validation a plus.
  • Previous establishment of validation systems for CDMO that engages in viral manufacturing.
  • Extensive experience with cost and schedule proposal and demonstrated adherence to the proposed schedules.

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.

North Carolina:

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.

Texas:

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.

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 place. 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.

Company

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.

Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.

Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.

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Find Us
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States
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