Senior Validation Engineer / Project Lead (Medical Devices)

Roles & Responsibilities

• Plan, lead, and coordinate project execution and validation activities, ensuring compliance with regulatory standards (ISO 13485, ISO 14971).
• Support and execute validation planning and protocols for equipment, process, and product transfers, specifically managing IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• Author, review, and approve validation documentation, ensuring traceability and adherence to quality system regulations.
• Collaborate effectively with cross-functional teams (Quality, Production, Engineering) to resolve technical issues and streamline project workflows.
• Act as the primary point of contact, coordinating with customers, manufacturing plants, and off-shore teams to ensure project continuity and timely delivery.
• Contribute as a Project Manager (PM) or Project Lead (PL) to drive project milestones (an added advantage).

Skills & Qualifications

• Domain Expertise: Mandatory prior experience in the Medical Devices industry.
• Regulatory Knowledge: Deep understanding of ISO 13485 (Quality Management) and ISO 14971 (Risk Management).
• Validation Expertise: Proven hands-on experience with IQ, OQ, and PQ protocols for equipment and process transfers.
• Documentation: Strong technical writing skills for authoring and reviewing validation protocols/reports.
• Coordination: Proven ability to manage cross-functional teams and global stakeholders (offshore and onshore).
• Experience: Experience as a Project Manager (PM) or Project Lead (PL) handling full project lifecycles (an added advantage).