The QA Engineer, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Engineer, DSM ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
Job DescriptionWhat You’ll Do
Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM programAssesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operationProvides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reportsGenerates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing SystemsGenerates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facilityEnsures project and operational quality objectives are met within desired timelinesCollaborates and aligns with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiencyParticipates in optimization or improvement initiatives and support regulatory agency and third‐party inspections.Performs other duties as assigned.
Minimum Requirements:
BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable GMP industry experience ORMS in Life Sciences or Engineering and 3+ years of applicable experience ORPhD in Life Sciences or Engineering and with 1+ years of applicable experience3+ years of experience working in a GMP regulated environmentExperience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.Experience in Commissioning, Qualification, and Validation (CQV), Current Good Manufacturing Practices (cGMP) manufacturing operations and/or Quality oversight, in a Food and Drug Administration (FDA) regulated facility.
Preferred Requirements:
Experience and working knowledge of ASTM E2500, Smartsheets, TrackWise, Veeva, and/or Kneat validation software.Experience with Greenfield or startup projects or initiatives.Familiarity/understanding of qualification / validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT systems, clean rooms, classified spaces, controlled temperature units (CTUs), Cleaning verification and validation, Clean in Place (CIP) / Steam in Place (SIP), and associated testing methodologies.
Physical and Work Environment Requirements:
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 30 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
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.
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