Engineer 3, Process Validation

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

The Engineer or Scientist 3 for Process Validation helps ensure that manufacturing processes meet the validation and regulatory requirements for the process to be reproducible under normal operating conditions. This role contributes to the design, execution, and documentation of process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works with cross-functional teams to help ensure 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 5 years of relevant experience (e.g., engineering); or Master’s degree in Engineering, Life Science or Chemical Engineering with 3 years of relevant experience (e.g., engineering); or PhD with no prior experience
Experience using Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)
Experience using Risk Management and RCA tools

Nice To Haves

Experience working in a Good Manufacturing Practices (GMP)environment
Prior drug substance manufacturing experience, including processvalidation
Experience with regulatory audits, inspections and requirements,such as FDA 21 CFR part 11

Responsibilities

Ensures regulatory compliance, assesses change notifications, and provides input on process validation related matters
Supports the team with process validation requirements
Plays a role in developing process validation strategy and executes 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 (PQ) execution and assessments for at-scale process validation requirements (e.g., worst-case soiling for cleaning validation, microbial hold, and mixing validation)
Provides support to process sub-teams throughout the phases of technology transfer (TT)
Generates 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.
Contributes to the development and implementation of training for manufacturing staff on process validation requirements
Facilitates troubleshooting, conducts process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations, as needed
Supports 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)
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
Participates in continuous improvement projects, in partnership with manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
Other duties, as assigned