Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
About This Role
The Sr Engineer or Scientist of Process Validation 1 ensures that manufacturing processes meet the validation and regulatory requirements to ensure the process is robust and reproducible under normal operating conditions. This role involves designing, executing, and documenting process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works closely with cross-functional teams to ensure that processes are consistently producing high-quality products in a safe and efficient manner.
What You’ll Do
- Provides oversight and supports the team with process validation requirements
- Ensures regulatory compliance, assesses change notifications, and provides strategic input on process validation related matters
- Develops process validation strategy and leads execution of all aspects of process validation including process performance qualification runs, continued process verification, and other validation studies
- Works with Validation (CQV) to support Performance Qualification execution and assessments for at-scale process validation requirements (e.g., worst-case soiling for cleaning validation, microbial hold, and mixing validation)
- Supports process sub-teams throughout the phases of technology transfer (TT)
- Leads generation of sampling plans for process validation reports (PVRs) and investigations
- Writes and reviews documentation for internal and external use such as validation campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments, etc.
- Develops and implements training for manufacturing staff on process validation requirements
- Leads or supports troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations, as needed
- Serves as subject matter expert (SME) to support TT stage gate reviews on incoming processes for manufacturing readiness (e.g., acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for proposed changes)
- As technical SME, leads or supports generation of master plans, viral segregation risk assessments, process risk assessments, contamination control strategy, extractable and leachable assessment, and other site procedures/policies
- Leads continuous improvement projects, in partnership with manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
- Deploys and maintains Large Scale Business Unit (LSBU) strategic roadmap for continuous and breakthrough improvements, and associated requirements
- Other duties, as assigned
Knowledge and Skills
- Network with key contacts outside own area of expertise. Adapts style and uses persuasion in delivering messages that relate to the wider firm business.
- Frequently advises others on complex matters. May be accountable through team for delivery of tactical business targets.
- Organizational impact and influence
- Ability to successfully navigate high stakes, crucial conversations
- Ability to distill complex concepts into meaningful information for all audiences
- Ability to generate mechanistic and theoretical hypotheses
- Ability to effectively present information to othersStrategic thinking and self-directed
- Proficient in use of Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)
- Strong knowledge of process validation principles across all 3 stages (Process Design, Process Qualification, and Continued Process Verification)
- Excellent communication and teamwork skills
- Ability to remain current on regulatory and quality requirements for manufacturing
Basic Requirements
- Bachelor's degree in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience; or
- Master's degree in in Engineering, Life Science or Chemical Engineering with 6 years of relevant experience; or
- PhD with 3 years of relevant experience
- Experience using Risk Management and root cause analysis tools
- Experience working in Good Manufacturing Practices (GMP) environment
Preferred Requirements
- Prior drug substance or manufacturing experience, including expertise in new product launch, process validation and commercialization
- Experience with regulatory audits and inspections and regulatory requirements such as FDA 21 CFR part 11
- Experience supporting or writing portions of regulatory filings
- Experience managing global or multi-site validation programs
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.