Opening with our client for a Production Equipment Qualification & Validation Engineer to provide technical knowledge and expertise to assist in the creation of the qualification and validation programs within a pharmaceutical manufacturing and laboratory environment.
The ideal candidate will have a background in pharmaceutical science or engineering, and have at least 5 years of experience with equipment qualification production equipment 21 CFR ( 21 CFR part 11, part 210, part 210)
Evaluate, develop, and implement program improvements for the qualification, validation, change management, calibration, and maintenance programs for equipment, facilities, and laboratory instrumentation.
Develop and review pre and post execution qualification and validation protocols (IQ, OQ, and PQ), calibration forms, and change management documents of equipment, facilities, and laboratory instrumentation. Maintain the qualification protocols, forms, and change control files.
Audit equipment/facility files to ensure qualifications are complete and accurate, and subsequent changes have been properly documented.
Develop and review introduction of new equipment/facilities into the Enterprise Management Application (SAP), determining cGMP status and ensuring the PM schedules are appropriate; temporary extensions to calibration and PM intervals; controlled lists and drawings for equipment, facilities and tooling, calibration and maintenance tasks and procedures; calibration, equipment, facility, or facility systems related investigations.
Track, trend, report on qualification, change management and calibration programs.
Requirements and Qualifications
Bachelor's Degree in engineering or related area
5+ years of experience with equipment qualification production equipment 21 CFR ( 21 CFR part 11, part 210, part 210)
Strong documentation and reporting experience; Hands on experience (working on shop floor to validate equipment and writing reports based on findings.)
Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry
Knowledge and understanding of pharmaceutical manufacturing equipment, facilities, and laboratory instrumentation preferred
Familiarity with Manufacturing, Regulatory Affairs, Quality Assurance, and Quality Control environments preferred
Excellent organizational and deductive reasoning skills.
Strong technical writing and communication skills
Production Equipment Qualification & Validation Engineer - 20496
Internal Number: 20496
About Oxford Solutions, Inc. - Pittsburgh, PA
Since 1998, Oxford Solutions has solidified our reputation as a reliable, cost-effective staffing solutions provider…whether it’s a mission-critical project of any magnitude, or simply to fill a necessary temporary opening to keep operations running smoothly.