FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Cleaning Validation Engineer (internally known as Manufacturing Senior Process Engineer - Cleaning Validation).  This is an upper level position in the Manufacturing Technology Support (MT&S) department at FDBU. This position will report directly to the Director, MT&S.

The successful candidate works independently and with colleagues to provide expertise and assistance for the design, development, standardization and maintenance of an operational biotechnology utilized in the manufacture of proteins and drug substances. This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography. Core manufacturing technologies include Weigh and Dispensing, Mixing and Buffer Preparation, Parts washing and Sterilization, and Homogenization.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Primary responsibilities supporting Cleaning Validation will include development and execution of cleaning validation programs for new products, overseeing requalification program for existing equipment/facilities, implementation of new cleaning technologies and approaches, authoring Semi-Annual Cleaning Monitoring Reports, supporting client and regulatory inspections, and
• Other MT&S duties include developing, executing and implementing operational excellence projects to increase manufacturing efficiencies for personnel and equipment, training/certifying manufacturing personnel, leading Problem Analysis sessions in support of manufacturing events, authoring investigation summaries, identify and implement CAPAs, author GMP documents (i.e., deviations, Change controls, SOP/Work Instruction/Batch records revisions, etc.).
• Other responsibilities include Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach including:
• (Man) Develop and deliver effective skill building and training plans for a given operational technology to manufacturing technicians
• Collaborate with individuals and teams of technicians & coaches on self-development plans
• Implement e-learning, video, classroom and in suite design and delivery as appropriate
• Create and maintain the technical training manuals and personnel certification process.
• Develop and assure alignment of training and skill building activities to site business requirements
• Assure local operational practice reflect local procedure and instruction.
• Provide guidance and direction on cross-functional training initiatives
• (Materials) Understand process control and material inputs to ensure capable and acceptable process output
• (Machinery) Understand technology operation capabilities, limits and control strategies
• Develop and/or Approve equipment qualification limits
• Set Calibration Tolerances and Approve Out of Tolerance Investigations
• Represent the manufacturing unit for equipment purchase, new technology and changes to equipment
• (Methods) Develop and maintain Technical Operational Manuals/Standard Operating Procedures/Work Instructions/Batch Records
• Lead operational technology standardization, standard batch templates and instruction interfaces and lead continuous improvement for a given technology
• Interface with Process Development and Process Sciences to transfer processes into the manufacturing plant
• Develop and approve procedures and batch records

BACKGROUND REQUIREMENTS:

• A BS/BA in science, engineering or other related field is preferred.
• 5-8 years’ experience with degree (7-12 years’ experience without a degree). At least 3 years’ experience in the biotech industry is required. Plant experience is preferred.
• Good working knowledge of cGMP requirements
• Experience in developing training materials preferred
• Experience conducting and evaluating training required
• Experience with laboratory and/or manufacturing instruments/equipment required
• Experience with Biotech/pharmaceutical processes required
• Previous leadership experience desired
• Due to the various interactions with external and internal groups, interpersonal, leadership and organizational skills are essential attributes. Must have the ability to work in a cross functional team environment.

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.

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.