Senior Process Validation Engineer - GMP/CMC Leader

incog; Fishers (IN); On-site; USD 110,000 - 140,000; Full time

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 for clinical and commercial programs. You will independently perform Process Performance Qualifications, mentor junior staff, collaborate with cross-functional teams, manage client communications and support regulatory submissions.

Bachelor’s degree in Science or Engineering; 3–5 years GMP experience; strong CMC knowledge and

Qualifications

• Bachelor’s degree in Science or Engineering is required.
• Master’s degree in Science or Engineering is preferred.
• 3–5 years of GMP experience is required.
• 2+ years of process validation experience for formulation, aseptic filling and/or combination product processes.
• Strong understanding of CMC regulatory requirements and process validation methodologies.
• Advanced analytical and problem-solving skills with demonstrated leadership capabilities.
• Excellent communication skills and proven ability to lead cross-functional teams and manage client relationships.

Responsibilities

• Lead TSMS Process Validation activities by providing advanced technical guidance to operations and technical transfer project teams on Process Performance Qualification with minimal supervision.
• Independently create complex process qualification documentation such as Process Validation Master Plans, Protocols, Summary Reports, and related validation documents for multiple product lines.
• Serve as technical lead in project teams and manage customer communications. Recognized as Subject Matter Expert for multiple manufacturing processes.
• Author and review complex GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms across multiple programs.
• Monitor and analyze Process Data across multiple manufacturing areas, identify trends and implement corrective actions independently.
• Lead technical troubleshooting and investigations of complex process issues to support comprehensive root cause analysis, product impact assessment and effective corrective and preventive actions.
• Lead cross-functional teams in assessing and implementing new technology for GMP manufacturing with strategic impact.
• Provide advanced technical guidance to team members in technical matters of process validation and mentor Entry Level engineers.
• Conduct comprehensive impact assessments of changes to the product, process, equipment, procedures and/or materials across multiple programs.
• Demonstrate strong understanding of CMC regulatory requirements specifically with respect to process validation and support regulatory submissions.
• Effectively engage and collaborate with both internal and external team members across cross-functional groups and lead client interactions.
• Lead identification of continuous improvement opportunities and drive implementation of those improvements with measurable impact.
• Stay current with trends and practices in the industry to support best in class processes and share knowledge with team members.
• Other responsibilities as required.

Skills

GMP experience

Process validation

Leadership

Cross-functional teamwork

Communication

Analytical/problem-solving

Education

Bachelor's degree in Science or Engineering

Master's degree preferred

Tools

Microsoft Office

Statistical analysis software

Data analysis tools

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 for clinical and commercial programs. You will independently perform Process Performance Qualifications, mentor junior staff, collaborate with cross-functional teams, manage client communications and support regulatory submissions.

Bachelor’s degree in Science or Engineering; 3–5 years GMP experience; strong CMC knowledge and