Senior Process Validation Engineer

Lead Candidate; 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 - Technical Services and Manufacturing Sciences (TSMS) will be responsible for leading all facets of Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will provide advanced technical leadership to ensure robust and reliable production processes are established and maintained across multiple programs

WHAT?

• 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

YOU!

• Bachelor's degree in Science or Engineering required
• Master's degree in Science or Engineering preferred
• 3-5 years of GMP experience required
• 2+ years of experience in process validation principles for formulation, aseptic filling and/or combination product (device assembly) processes

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.