FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Senior Manufacturing Process Engineer (Validation). This person 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:
- Design and Execute multiple large and small scale validation projects using a risk based validation
- Coordinate/oversee the development of new processes or troubleshoot existing ones.
- Executes equipment, facility, and utility validation activities to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.
- Participates and presents data in Regulatory Agency, Customer, Corporate and Internal audits.
- Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.
- Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
- Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
- Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).
- Perform certification of manufacturing technicians in specific unit operations (e.g., fermentation, UF, chromatography, etc.)
- 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.).
- Provide guidance and direction on cross-functional training initiatives
- Develop and/or Approve equipment qualification limits and set Calibration Tolerances and Approve Out of Tolerance Investigations
- 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.
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.