Sr Scientist-Engineer 1, Process Validation

Fujifilm•Holly Springs, NC

20h•Onsite

About The Position

The Senior Engineer or Scientist of Process Validation 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.

Requirements

Bachelor's degree in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience (e.g., engineering)
Master's degree in in Engineering, Life Science or Chemical Engineering with 6 years of relevant experience (e.g., engineering)

Nice To Haves

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

Responsibilities

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 (PPQ) runs, continued process verification, and other validation studies
Partners 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, 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 and 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