Performance Validation, LLC is an employee owned company providing commissioning, qualification and validation services to the pharmaceutical and medical device industries. We develop and execute test procedures for pharmaceutical utility systems and process equipment that ensure compliance with Food and Drug Administration (FDA) and current Good Manufacturing Practices (cGMP) regulations.
Performance Validation, LLC is a cross-section of individuals with science and engineering degrees in various disciplines and individuals with technical military backgrounds. The environment is challenging and growth-oriented and fosters teamwork and collaboration. Unlimited opportunities exist for those who possess the desire and willingness to succeed.
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 timeline 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.
This full-time position is with our Indiana region and requires the ability to travel a minimum of 25%, if needed.
Minimum Qualifications: 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: 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.
- 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).
Performance Validation offers an excellent compensation package including benefits such as medical and dental insurance, profit sharing bonuses, 401(k) with company match, and life and disability insurance.
Performance Validation is an Equal Opportunity Employer.