Performance Validation, LLC (PV) has provided Commissioning, Qualification and Validation services to the life science industries for over 20 years. PV is an Indiana LLC company with local offices in Indiana and Michigan providing support throughout the US and overseas. PV is committed to providing growth opportunities to its employees through professional development, implementation of new services and cultivation of new geographical areas.
Performance Validation is seeking a Validation Engineer/Specialist to demonstrate a sound knowledge, application and proper implementation of technical, quality and scientific principals necessary to meet industry and customer requirements. This individual is expected to work in a team environment or independently to meet defined objectives based on an established timelines and deliver project work in a manner that is consistent with the company’s values. The activities would include:
- Development of Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports.
- Execution of Test Protocols, including identification and resolution of non-conformances/deviations.
- Tracking and managing change control activities for multiple concurrent projects.
A Bachelors degree in Engineering, Management, Life Sciences, or other related technical field (or equivalent military training) with two or more years experience in pharmaceutical or other regulated industry.
Experience with any of the following: Process Equipment, filling or packaging equipment, lyophilzation, thermal mapping, critical utilities (Nitrogen, Compressed Air, Clean Steam, HVAC Validation, Compendia Water Systems), sterilization/depyrogenation, cleaning validation planning and execution, fermentation/bioreactors, PLC/DCS Systems, P&ID Development.
The candidate must:
• Have excellent writing skills.
• Be a self-starter and be motivated to provide a solid product quality and customer experience.
• Possess effective skills for developing, performing, evaluating, troubleshooting for operating systems and controls, or within a specific scientific / technical discipline.
• Well-developed knowledge of pharmaceutical industry standards and requirements (e.g. cGMPs, GAMP, ICH, ISPE baseline guide, ASTM E2500).
This position is located in Kalamazoo, Michigan supporting Pharmaceutical and Medical Device manufacturers, and may require 25% travel.