Commissioning Qualification Engineer
Job in
Scranton, Lackawanna County, Pennsylvania, 18512, USA
Listed on 2026-05-31
Listing for:
Staftonic LLC
Full Time
position Listed on 2026-05-31
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Process Engineer, Quality Engineering
Job Description & How to Apply Below
We are seeking a commissioning qualification engineer to support commissioning, startup, and qualification activities for new GMP sterile manufacturing systems and utilities.
Responsibilities- Execute commissioning, IQ/OQ, and startup activities
- Support qualification of sterile manufacturing equipment and clean utilities
- Coordinate with engineering, automation, quality, and operations teams
- Review P&IDs, vendor documents, and turnover packages
- Troubleshoot commissioning and qualification issues
- Ensure GMP compliance and support regulatory readiness
- Sterile filling lines
- Vial washers & sterilizers
- Isolators & aseptic processing equipment
- WFI, clean steam, HVAC, and process utilities
- Bachelor’s degree in Engineering or related field
- 2–5 years of C&Q/Validation experience in GMP environments
- Experience with sterile manufacturing or aseptic processing preferred
- Knowledge of fill-finish systems, lyophilizers, and clean utilities preferred
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