Senior Process Validation Engineer - GMP Leader

INCOG BioPharma Services; Fishers (IN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Smoke-free campus

Equal opportunity employer

Job summary

INCOG BioPharma Services in Fishers, IN is seeking a Senior Process Validation Engineer to lead Process Validation, GMP Floor Support, and Continued Process Verification across multiple programs. You will drive qualification activities and mentor junior staff while ensuring robust manufacturing processes.

The role requires hands-on leadership, deep knowledge of cGMP and CMC requirements, and the ability to author complex validation documentation, analyze process data, and coordinate

Qualifications

• 3–5 years of GMP experience.
• 2+ years in process validation for formulation/aseptic filling.
• Strong understanding of CMC regulatory requirements.
• Excellent communication and leadership abilities.

Responsibilities

• Lead TSMS Process Validation activities with minimal supervision.
• Create Master Plans, Protocols, Summary Reports and related docs.
• Serve as technical lead and SME for multiple processes.
• Author GMP documentation and review Master Batch Records.
• Monitor process data, identify trends, and drive CAPA.
• Lead investigations for root-cause analysis and corrective actions.
• Mentor Entry Level engineers and cross-functional teams.

Skills

Process Validation

Leadership

Analytical thinking

Communication

Education

Bachelor's degree in Science or Engineering

Master's degree preferred

Tools

Microsoft Office

Statistical software

Job description

INCOG BioPharma Services in Fishers, IN is seeking a Senior Process Validation Engineer to lead Process Validation, GMP Floor Support, and Continued Process Verification across multiple programs. You will drive qualification activities and mentor junior staff while ensuring robust manufacturing processes.

The role requires hands-on leadership, deep knowledge of cGMP and CMC requirements, and the ability to author complex validation documentation, analyze process data, and coordinate