About this opportunity
Lead Candidate Ltd lists this Senior Process Validation Engineer opportunity in indiana, Pennsylvania. Review the employer’s description below for duties, qualifications and application requirements.
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.
#J-18808-Ljbffr
Worksite address
indiana, PA, 15705, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.