Description

Lead thermal validation and change control for critical manufacturing equipment.

This role is on-site.

Responsibilities

• Execute IQ, OQ, and PQ protocols for autoclaves, isolators, tunnels, and process skids.
• Manage change control processes and support CAPA, including non-conformance and deviation investigations.
• Develop validation plans, cycle development studies, and technical assessments.
• Draft and revise engineering documentation, including SOPs, work instructions, and preventative maintenance task lists.
• Participate in FAT, SAT, and critical test plan execution for equipment commissioning and decommissioning.

Required Skills

• 5+ years in technical validation or engineering roles.
• Experience with Acceptance Testing and Site Acceptance Testing (SAT).
• Proficiency in test planning and engineering documentation.
• Ability to manage SOP development and technical services.
• Experience with equipment decommissioning and troubleshooting.
• Background in software development related to technical systems.

Preferred Skills

• Any Graduate degree.

Key Skills

Education

Any Graduate