Senior Process Validation Engineer for Biotech

Merck & Co.; Holly Springs (NC); On-site; USD 115,000 - 150,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Engineer or Scientist to oversee process validation, ensuring regulatory compliance and robust, reproducible manufacturing processes.

You will design and execute validation protocols, partner with CQV, support tech transfer, and lead root-cause analysis for deviations, while training manufacturing staff.

This role offers the opportunity to contribute to early-stage and scale-up processes within a dynamic biopharma environment.

Qualifications

• Bachelor's degree in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience.
• Master's degree in Engineering, Life Science or Chemical Engineering with 6 years of relevant experience.

Responsibilities

• Provides oversight and supports the team with process validation requirements.
• Develops process validation strategy and leads execution of PPQ runs, continued process verification, and other validation studies.
• Partners with Validation (CQV) to support PQ execution for at-scale validation requirements.
• Supports process sub-teams throughout technology transfer (TT).
• Leads generation of sampling plans for process validation reports (PVRs) and investigations.
• Writes and reviews validation documentation and develops training for manufacturing staff on process validation requirements.

Skills

Process validation

Regulatory compliance

PPQ execution

Cross-functional collaboration

Documentation

CAPA and RCA

Validation master plans

Education

Bachelor's degree in Engineering/Life Science/Chemical Engineering

Master's degree in Engineering/Life Science/Chemical Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Engineer or Scientist to oversee process validation, ensuring regulatory compliance and robust, reproducible manufacturing processes.

You will design and execute validation protocols, partner with CQV, support tech transfer, and lead root-cause analysis for deviations, while training manufacturing staff.

This role offers the opportunity to contribute to early-stage and scale-up processes within a dynamic biopharma environment.