Just is seeking a recognized Validation leader in the Manufacturing Technical Operations group that desires a significant opportunity to improve worldwide access to biotherapeutics. The Director of Validation role will be responsible for building a team of engineers and scientists to lead commercial readiness validation activities for our Redmond manufacturing facility. The selected candidate will establish and direct the execution, resources, business processes, and validation program oversight. A key area of focus for the successful candidate will be building the business process for our late-stage clinical and commercial programs, including defining the process validation strategy, and supporting regulatory filings and agency interactions. The candidate will also collaborate with Manufacturing, Facilities & Engineering, Quality, and Regulatory teams, as well as interact with clients, auditors, and regulatory agencies to ensure compliance and successful approval of our commercial facility.
- Reporting to the VP of Technical Operations, the successful candidate will have responsibility for leading the rapidly growing Validation organization, including recruiting, and employee development.
- Lead the team that owns the Validation programs for facilities, utilities, process equipment, and process validation including validation related exceptions/deviations, CAPAs, and change controls.
- Partner with the Facilities Engineering and Quality Assurance Validation teams to ensure GMP utilities and equipment have a successful and compliant initial validation and are subsequently maintained in a validated state.
- Establish global Validation programs, standards, and procedures for the portfolio of GMP manufacturing facilities.
- Oversee validation execution work according to protocol instructions and procedures and ensure high quality and compliant validation packages and reports are approved and kept current.
- Support the establishment of a clear and inherent culture of Quality First and Right First Time that ensures high transparency and collaboration between Quality, Operations and Tech Ops.
- In collaboration with Regulatory, author regulatory submissions related to the validation of facilities, utilities, equipment, and manufacturing processes and serve as a subject matter expert in regulatory interactions related to the Validation programs.
- B.S. or higher degree in engineering science or related program with 15+ years of pharmaceutical/biotech validation experience including a minimum of 5-10 years of experience leading a GMP Validation team.
- Extensive knowledge and experience with late-stage clinical and commercial biologics drug substance manufacturing programs, including project leadership roles in process validation, PPQ, and commercial validation.
- GMP Validation experience including Validation Master Plans, process, utility, and facility IQ/OQ/PQ, QC lab equipment validation, process validation (including PPQs and CPV), cleaning validation, hold time studies, and mixing studies.
- Recognized expert in the field of validation, and solid understanding of upstream and downstream process equipment, QC lab equipment, facility equipment such as autoclaves and WFI systems, and disposable manufacturing technologies.
- Experience in BLA section authoring, PAI readiness and inspection support.
- Demonstrated leadership capabilities to build and mentor high performing teams, drive change, and influence internal and external stakeholders.
- Significant experience with process risk assessment tools (e.g. FMEA), and facilitating risk assessments.
- Strong analytical and structured problem-solving skills.
- Proven knowledge of cGMP requirements and experience writing manufacturing technical documents.
- Excellent verbal and written communication skills; ability to interface with all levels of the organization and build productive relationships with team members and stakeholders across the organization.
Additional Preferred Qualifications:
- Working knowledge of DeltaV and process automation.
- Experience with leachables and extractables assessments.
- Experience in computer software validation in both writing test scripts and executing test protocols is strongly preferred