Description

You will lead thermal validation activities and change control processes for critical manufacturing equipment.

Responsibilities

• Execute validation protocols including IQ, OQ, and PQ for equipment such as autoclaves, isolators, tunnels, and process skids.
• Manage Change Control and CAPA support, 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 to support equipment commissioning and decommissioning.

Required Skills

• 5+ years of experience 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.
• Any Graduate degree.

Preferred Skills

• Experience with Kneat template development and Kaye Validator firmware upgrades.

Key Skills

Education

Any Graduate