Senior Process Validation Engineer – GMP Leadership

Lead Candidate Ltd; Indiana (PA); On-site; USD 110,000 - 140,000; 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

INCOG is seeking a Senior Process Validation Engineer - TSMS to lead Process Validation, GMP Floor Support, and Continued Process Verification across clinical and commercial programs. You will provide advanced technical leadership to establish and maintain robust production processes.

Responsibilities include creating Master Validation Plans, Protocols, Summary Reports, and related documentation; serving as SME on multiple manufacturing processes; and guiding tech transfer and cross‑functional

Qualifications

• Bachelor's degree in Science or Engineering required.
• Master's degree preferred.
• 3-5 years of GMP experience required.
• 2+ years in process validation principles for formulation or aseptic filling.

Responsibilities

• Lead TSMS Process Validation activities and provide advanced technical guidance to operations and project teams on Process Validation.
• Create complex process qualification documentation such as Master Plans, Protocols, and Summary Reports for multiple product lines.
• Serve as technical lead in project teams and act as SME for multiple manufacturing processes and customer communications.
• Author and review GMP manufacturing documents including Master Batch Records, BOMs, and Processing Forms across programs.

Skills

GMP experience

Process validation principles

Technical leadership

Education

Bachelor's degree in Science or Engineering

Master's degree in Science or Engineering

Job description

INCOG is seeking a Senior Process Validation Engineer - TSMS to lead Process Validation, GMP Floor Support, and Continued Process Verification across clinical and commercial programs. You will provide advanced technical leadership to establish and maintain robust production processes.

Responsibilities include creating Master Validation Plans, Protocols, Summary Reports, and related documentation; serving as SME on multiple manufacturing processes; and guiding tech transfer and cross‑functional