Katalyst CRO
Senior Validation Engineer
Location: North Salt Lake, UT | Salary: $64,000.00 – $83,000.00 (3 days ago)
Responsibilities
Develop and execute validation strategies
Lead Process Validation & PPQ activities
Perform C&Q for equipment, utilities, and facility systems
Run risk and gap assessments
Maintain equipment master data and support change controls
Execute floor-level validation in GMP cleanrooms
Coordinate sampling and data collection
Support recipe authoring, data trending, and automation needs
Train and guide cross‑functional teams
Qualifications
Bachelor's in Engineering
5+ years in biopharma validation/process engineering
Strong process validation & equipment qualification experience
cGMP, FDA/EMA, ICH Q7/Q10 knowledge
MES, automation, LIMS exposure
Cleanroom and hands‑on lab skills
Strong communication & documentation abilities
Seniority level Associate
Employment type Contract
Job function Pharmaceutical Manufacturing
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Responsibilities
Develop and execute validation strategies
Lead Process Validation & PPQ activities
Perform C&Q for equipment, utilities, and facility systems
Run risk and gap assessments
Maintain equipment master data and support change controls
Execute floor-level validation in GMP cleanrooms
Coordinate sampling and data collection
Support recipe authoring, data trending, and automation needs
Train and guide cross‑functional teams
Qualifications
Bachelor's in Engineering
5+ years in biopharma validation/process engineering
Strong process validation & equipment qualification experience
cGMP, FDA/EMA, ICH Q7/Q10 knowledge
MES, automation, LIMS exposure
Cleanroom and hands‑on lab skills
Strong communication & documentation abilities
Seniority level Associate
Employment type Contract
Job function Pharmaceutical Manufacturing
#J-18808-Ljbffr