QA Engineer, DSM Operations (2-2-3, 0600 - 1800)

QA Engineer, DSM Operations

The QA Engineer, DSM Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes through to operational readiness during project phase. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues. This role works 12-hour day shift on a 2-2-3 cadence, 0600-1800.

Job Description

What You'll Do

Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM program

Assesses 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 operation

Provides 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 reports

Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems

Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility

Ensures project and operational quality objectives are met within desired timelines

Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency

Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections

Works 12-hour shift on 2-2-3 cadence, 0600-1800

Performs other duties as assigned

Minimum Requirements :

BS / BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR

MS in Life Sciences or Engineering and 3+ years of applicable experience OR

PhD in Life Sciences or Engineering and with 1+ years of applicable experience

3+ years of experience working in a GMP regulated environment

Experience in Validation, cGMP manufacturing operations and / or Quality oversight, in an FDA regulated facility.

Preferred Requirements :

Working knowledge and experience with ASTM E2500, Smartsheet, Trackwise, MasterControl and / or Kneat validation software

Experience with startup projects or initiatives

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.