Laboratory Validation Engineer II

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The 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 Manger. Role Responsibilities Execute 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 systems. Develop and manage qualification lifecycle documentation and activities including qualification plans, protocols, reports, change controls, and deviations. Author 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 lifecycle. Collaborate with cross-functional teams such as Quality Assurance, Laboratories, Metrology, Engineering, IT, and external vendors to ensure successful qualification execution. Evaluate and apply risk-based qualification approaches aligned with current industry guidance and standards. Write periodic reviews and support continuous monitoring of qualified systems and laboratory equipment. Ensure compliance with ALCOA/ALCOA+ data integrity principles and electronic records requirements. Assist in development and improvement of qualification strategies, procedures, and best practices. Qualifications Bachelor's degree in biology, Chemistry, Engineering, Pharmaceutical Sciences, or 5+ 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 systems. Knowledge of analytical instrument qualification (AIQ) practices. Strong technical writing, communication, and organizational skills. Sound knowledge of GMP regulations, internal SOPs, FDA regulations applicable to laboratory operations, 21 CFR Part 11 requirements, Data Integrity principles, change control, and deviation management. Familiarity with audit trail review processes and electronic data management systems preferred. Experience authoring User Requirement Specifications (URS) and qualification documentation for laboratory instruments and computerized systems preferred. Strong knowledge of laboratory instrumentation and qualification lifecycle methodologies preferred. California residents should review our Notice for California Employees and Applicants before applying. Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. #J-18808-Ljbffr Kindeva Drug Delivery