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Prepare and review requirements, risk assessments, validation plans, and final reports.
Support FAT/SAT activities and coordinate with equipment vendors.
Investigate validation deviations and support resolution.
Partner with Engineering, Manufacturing, and Quality to ensure GMP compliance and production readiness.
Qualifications5+ years of equipment validation experience in pharmaceutical or medical device manufacturing.
Hands-on experience qualifying packaging or automated assembly equipment.
Experience writing and executing
Strong GMP documentation and communication skills.
Experience with cartoners, case packers, palletizers, labeling systems, conveyors, or Kneat is desiredQualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
SE
Sterling Engineering, Inc.
Sr Validation Engineer (Equipment)
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Job Description
Position:
Equipment Validation Engineer -PackagingDuration:
24+ months /Long-Term ContractLocation:
Waukegan, IL 60087 Onsite, 5 Days per Week | W2 Only — No C2C I am looking for Sr Validation Engineer with 7+ years of U.S. experience to join our Sterling Engineering team. In this role you will be supporting packaging and automated assembly equipment in pharmaceutical manufacturing environment. ResponsibilitiesDevelop and execute equipment qualification protocols (IQ/OQ/PQ).Support equipment installation, commissioning, qualification, and startup.Prepare and review requirements, risk assessments, validation plans, and final reports.
Support FAT/SAT activities and coordinate with equipment vendors.
Investigate validation deviations and support resolution.
Partner with Engineering, Manufacturing, and Quality to ensure GMP compliance and production readiness.
Qualifications5+ years of equipment validation experience in pharmaceutical or medical device manufacturing.
Hands-on experience qualifying packaging or automated assembly equipment.
Experience writing and executing
IQ/OQ/PQ
protocols, resolving deviations, and completing validation reports.Strong GMP documentation and communication skills.
Experience with cartoners, case packers, palletizers, labeling systems, conveyors, or Kneat is desiredQualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
Benefits
- Dental Insurance