Laboratory Validation Engineer II

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThe successful candidate will support laboratory instrument qualifications and continuous compliance initiatives within a cGMP-regulated laboratory environment. This role is responsible for ensuring laboratory instruments; computerized systems and supporting processes are qualified maintained and compliant with applicable regulatory and industry standards. The position works closely with Quality Metrology and IT as well as write and execute qualification protocols of various types under the direction of Laboratory Validation ResponsibilitiesExecute and support qualification activities for laboratory instruments and computerized systems including IQ OQ requalification and periodic review activities; ensuring laboratory equipment and systems remain compliant with GMP requirements FDA regulations Data Integrity expectations and internal quality and manage qualification lifecycle documentation and activities including qualification plans protocols reports change controls and and review User Requirement Specifications (URS) for laboratory instruments and systems to ensure operational regulatory data integrity and business requirements are clearly defined and traceable throughout the qualification with cross-functional teams such as Quality Assurance Laboratories Metrology Engineering IT and external vendors to ensure successful qualification and apply risk-based qualification approaches aligned with current industry guidance and periodic reviews and support continuous monitoring of qualified systems and laboratory compliance with ALCOA/ALCOA data integrity principles and electronic records in development and improvement of qualification strategies procedures and best degree in biology Chemistry Engineering Pharmaceutical Sciences or5 years of laboratory testing experience in a GMP-regulated environment with a sound working knowledge of the operation of various laboratory instruments and equipment.3 years of experience qualifying laboratory equipment and of analytical instrument qualification (AIQ) technical writing communication and organizational knowledge of GMP regulations internal SOPs FDA regulations applicable to laboratory operations 21 CFR Part 11 requirements Data Integrity principles change control and deviation with audit trail review processes and electronic data management systems authoring User Requirement Specifications (URS) and qualification documentation for laboratory instruments and computerized systems knowledge of laboratory instrumentation and qualification lifecycle methodologies preferred.