Validation Engineer Job

A Validation Engineer is needed to perform the following duties:

· ● Documented and executed Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for critical manufacturing and utility systems including CIP skids, USP water systems, and TOC analyzers, ensuring compliance with GMP and site validation standards.

● Led qualification efforts for production line utilities such as filling machines, packaging equipment, label printers, tune weighing scales, and pig launchers, validating each system’s design, installation, and operational parameters against P&ID and URS requirements.

● Conducted verification and calibration of integrated components like flow meters, pressure sensors, actuators, and valves as part of utility and equipment qualifications to ensure system readiness and compliance.

● Represented Site for FAT visits and reviewed and approved SAT Documents.

● Directed and executed validation protocols under site-wide change control initiatives, including capital project validations and compliance-driven modifications, aligning deliverables with project timelines and regulatory expectations.

● Developed and implemented change control documentation (MOC), wrote and routed deviation reports, and led root cause analyses and impact assessments to address failed calibrations and equipment discrepancies.

● Adjusted qualification strategies dynamically in response to onsite challenges such as incorrect pipe slopes or failed instrumentation, redesigning test logic and protocol structures to ensure successful requalification.

● Acted as the primary validation liaison for cross-functional project teams including Engineering, Automation, Quality, and Operations, facilitating collaborative meetings to drive alignment on equipment commissioning and qualification readiness.

● Collaborated with global partners in Quality, R&D, and Supply Chain to support the development and qualification of new product formulations and line extensions, ensuring documentation and testing aligned with international compliance standards.

● Conducted weekly site readiness meetings with stakeholders to coordinate roles and responsibilities, resolve issues, and prepare for upcoming validation and commissioning milestones.

● Authored comprehensive validation documents including protocols, test scripts, summary reports, SOPs, and change controls in accordance with FDA, cGMP, and internal quality guidelines.

● Maintained audit-ready documentation and ensured validation traceability through structured document control, versioning, and cross-referencing against risk assessments and commissioning packages.

● Revised and implemented preventive maintenance (PM) plans based on post-qualification outcomes and manufacturer recommendations to ensure sustained equipment performance.

● Designed and executed sampling plans for USP water systems and process utilities, analyzing microbiological and chemical data to evaluate system suitability and process consistency during PQ.

● Interpreted and trended data to identify deviations, compiled deviation reports, and supported CAPA implementation to ensure ongoing compliance and reliability of critical utilities.

● Reviewed laboratory data and sampling forms for accuracy, ensuring results were within specified action and alert levels before report finalization.

● Conducted protocol training sessions for QA, Maintenance, and Operations teams prior to validation execution to ensure test case understanding and compliance with protocol requirements.

● Trained cross-functional team members on equipment functionality, SOPs, and system handling post-validation to ensure smooth handover and operational continuity.

● Mentored junior engineers and interns on validation documentation, commissioning steps, and troubleshooting approaches, fostering team knowledge and execution quality.

Bachelor's Degree in Mechanical Engineering or Engineering and Operations Management

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