Lead Process Validation Engineer, GMP & Tech Transfer

Lead Candidate Ltd; Indiana; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off

11 paid holidays

401(k) plan with company match

Health & wellness plans

FSA and HSA options

Onsite wellness facility

Employee engagement activities

Job summary

The Senior Process Validation Engineer in INCOG's TSMS organization leads validation, GMP floor support, and continued process verification across programs to ensure robust manufacturing. You will develop Master Plans, protocols, and summary reports with minimal supervision.

You bring 3–5 years of GMP experience and a strong background in formulation, aseptic filling, or combination product processes, plus a BS/BE (MS preferred) and leadership capabilities.

Qualifications

• Bachelor's degree in Science or Engineering is required.
• 3–5 years of GMP experience is required.
• 2+ years of experience in process validation for formulation, aseptic filling and/or combination product processes.

Responsibilities

• Lead TSMS process validation activities and provide advanced technical guidance to operations and transfer teams.
• Independently create complex qualification documents (PV Master Plans, Protocols, Summary Reports).
• Serve as technical lead in project teams and manage customer communications as SME for multiple processes.
• Author and review GMP manufacturing documents across programs.

Skills

GMP experience

Process validation

Technical leadership

Cross-functional teamwork

Education

Bachelor's degree in Science or Engineering

Master's degree in Science or Engineering preferred

Job description

The Senior Process Validation Engineer in INCOG's TSMS organization leads validation, GMP floor support, and continued process verification across programs to ensure robust manufacturing. You will develop Master Plans, protocols, and summary reports with minimal supervision.

You bring 3–5 years of GMP experience and a strong background in formulation, aseptic filling, or combination product processes, plus a BS/BE (MS preferred) and leadership capabilities.