QvalFocus Inc.

Compensation

Full Description

Location: Lancaster, PA (Semi-Local Preferred) | Remote with Occasional Onsite Must be willing to relocate locally through End of Year Travel to Europe required Duration: Contract through End of Year (Extension Possible) Experience Required: 5+ Years of GMP Validation experience in sterile / aseptic manufacturing environments Top Required Skills (Must-Have): • VHP (Vaporized Hydrogen Peroxide) validation experience • Steam-in-Place (SIP) / Sterilization validation • Cleanroom classification & environmental qualification • Aseptic filling line validation • IQ/OQ/PQ protocol authoring & execution • Capital project validation (SIA through VSR lifecycle) • Change control ownership & execution Key Responsibilities: • Provide validation support for Capital Projects and Pilot Plant initiatives (SIA through VSR lifecycle) • Generate and execute IQ/OQ/PQ protocols for aseptic processing equipment and utilities • Support validation of new systems including hydrogenation ovens, autoclaves, decontamination containers, parts washers, filling lines, and lyophilizers • Lead and execute VHP cycle development, validation, and documentation activities • Perform steam-in-place (SIP) / sterilization validation activities for aseptic systems • Conduct cleanroom classification and support environmental qualification activities • Author validation summary reports and ensure inspection-ready documentation • Own and execute change controls related to capital and pilot plant validation projects Equipment / Systems Exposure: • Hydrogenation ovens • Autoclaves • Decontamination containers • Parts washers • Aseptic filling systems • Lyophilizers