About the Company
The Validation Project Engineer is responsible for planning, executing, and managing validation activities to ensure equipment, systems, and processes meet regulatory, quality, and operational requirements. This role supports cross‑functional teams, leads validation projects from concept through completion, and ensures compliance with industry standards and internal procedures.
About the Role
This role supports cross‑functional teams, leads validation projects from concept through completion, and ensures compliance with industry standards and internal procedures.
Responsibilities
Lead validation projects across equipment, utilities, facilities, and manufacturing processes, ensuring timely and compliant execution.
Develop and execute validation documentation, including URS, DQ, IQ, OQ, PQ, risk assessments, and validation reports.
Manage project timelines, resources, and deliverables while coordinating with the wider engineering team quality, operations, and external vendors.
Ensure compliance with regulatory guidelines (e.g., FDA, GAMP 5) and internal quality systems.
Support equipment commissioning, FAT/SAT activities, and process qualification efforts.
Analyze validation data, identify trends or issues, and recommend corrective or preventive actions.
Contribute to continuous improvement initiatives, including process optimization and standardization of validation practices.
Ensure that engineering, qualification, and validation records are developed and maintained as per cGMP and GDP requirements.
Develop lifecycle activities including device innovation, concept generation, design reviews, specification development, device industrialization, manufacturing process development, validation, and design verification.
Lead the Equipment Qualification aspects of Projects on site.
Perform root cause analysis of Project issues when required.
Effectively communicate and discuss related day-to-day activity and concerns within the team for efficiency and performance improvement.
Coordinate with design consultants as required and respective user departments for the design/manufacturing of equipment.
Review and approval on detailed designs as submitted by vendors.
Ensure project execution work and follow-ups with different departments (QA, QM, Operations) to meet project completion within stipulated time frame.
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