MS&T Engineer – Validation & Qualification Specialist

About the role

The MS&T Engineer will support site validation and qualification activities within pharmaceutical or medical‑device manufacturing environments. You will develop and execute validation strategies, ensure regulatory compliance, and maintain documentation throughout equipment, process, and system lifecycles.

Key responsibilities

• Coordinate and support validation and qualification projects, including the creation of validation plans.
• Author and execute IQ, OQ, and PQ protocols in line with GMP requirements.
• Investigate deviations and drive corrective and preventive actions (CAPA).
• Prepare validation and qualification summary reports.
• Conduct risk assessments for products, processes, and systems.
• Support global packaging changes and act as subject‑matter expert for packaging‑related projects.
• Collaborate with cross‑functional teams and external vendors to resolve technical and packaging issues.

Required profile

• Minimum 4 years of experience in pharmaceutical or medical‑device manufacturing.
• At least 2 years creating or approving validation protocols.
• Hands‑on experience with validation/qualification activities and GMP compliance.
• Familiarity with deviation management, risk assessment, and CAPA processes.
• Experience in packaging validation or labeling review is a plus.

Required skills

• Validation protocol development
• GMP compliance
• IQ/OQ/PQ execution
• CAPA investigation
• Risk assessment
• Packaging validation

What we offer

• Generous leave policy and comprehensive health & wellness coverage.
• Professional development programs and continuous learning resources.
• Inclusive culture that encourages innovation, collaboration, and diverse perspectives.