Validation Engineer Job

Validation Engineer is needed to perform the following duties:

Prepare and review validation lifecycle documentation including User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with FDA and cGXP standards.
Author and manage Change Control documents, Summary Reports, Deviation Reports, Requirement Traceability Matrices (RTMs), and Requalification Protocols as part of the validation lifecycle.
Develop and maintain Standard Operating Procedures (SOPs) and Preventive Maintenance documentation for regulated systems and equipment.
Perform validation and compliance activities for GAMP-categorized software systems using ISPE’s GAMP4 and GAMP5 methodologies.
Participate in the validation and support of systems such as Laboratory Information Management System (LIMS), Scientific Data Management System (SDMS), Chromatography Systems, Adverse Event Reporting Systems, Document Management Systems (e.g., Veeva Vault), Quality Management Systems (e.g., TrackWise), and SAP R/3.
Conduct qualification activities for facilities, utilities, manufacturing equipment, and controlled environments, ensuring compliance with industry regulations and cGMP guidelines.
Author and execute cleanroom qualification protocols across environmental classifications GRADE A/B/C/D, including viable and non-viable particle monitoring.
Support gowning qualification, aseptic technique training, and sterile manufacturing processes in alignment with current Good Manufacturing Practices (cGMP).
Train end-users on validated systems and ensure proper implementation and adherence to controlled documentation.
Ensure regulatory compliance with FDA 21 CFR Parts 11, 58, 210, 211, 820, and 822 during all validation and documentation tasks.
Conduct validation activities in accordance with current Good Practice (cGXP) standards, including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).

· Provide ongoing validation support, documentation updates, and audit readiness for all qualified systems and processes.

Bachelor's Degree is required in Biomedical engineering.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave