Senior Process Engineer is a mid-level position in the Manufacturing Technology Support (MT&S) department at FDBU. This position will report directly to the Director, MT&S, but may also have a functional reporting relationship to a senior colleague on a project to project basis.
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:
- Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach including:
- 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
- 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.
English as a primary or secondary language. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from groups of trainees, management, clients, customers, and the general public.
Ability to apply mathematical concepts such as fractions, percentages, ratios. Math ability should be consistent with carrying out calculations in typical batch record documents.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Word processing, Spreadsheets, E-mail, Internet Software, Powerpoint, DCS/Unicorn/PI (as appropriate)
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. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.
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.