Senior Process Validation Engineer

Lead Candidate; Indiana (PA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

PTO

11 paid holidays

401(k) with company match

Health & wellness plans

FSA/HSA options

Onsite wellness facility

Team engagement activities

Job summary

Lead Candidate in a U.S. based facility seeks a Senior Process Validation Engineer to drive cGMP process validation, floor support, and continued verification. You will provide advanced technical leadership to ensure robust production processes across multiple programs and serve as SME for key manufacturing processes.

Qualifications

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

Responsibilities

• Lead TSMS Process Validation activities with guidance to operations and transfer teams.
• Create complex qualification documentation such as PV Master Plans and Protocols for multiple product lines.
• Serve as technical lead in project teams and SME for multiple manufacturing processes.
• Author and review GMP manufacturing documentation including Master Batch Records and Processing Forms across programs.

Skills

GMP experience

Process Validation

Technical leadership

Documentation writing

Education

Bachelor's degree in Science or Engineering

Master's degree in Science or Engineering

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

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.