Description

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

Responsibilities

• Execute validation protocols including IQ, OQ, and PQ for equipment such as autoclaves, isolators, and process skids.
• Manage Change Control and CAPA support, including non-conformance and deviation investigations.
• Develop validation plans, cycle development studies, and technical assessment reports.
• Coordinate documentation including SOP creation, work instructions, and preventative maintenance task lists.
• Support manufacturing through troubleshooting, decommissioning, and participation in FAT and SAT.

Required Skills

• 5+ years of experience in technical validation or engineering roles.
• Experience with Acceptance Testing and SAT/FAT protocols.
• Proficiency in Engineering Documentation and SOP development.
• Hands-on experience with troubleshooting and decommissioning processes.
• Ability to perform test planning and technical assessments.
• Knowledge of thermal validation and equipment qualification.
• Experience with Change Control and CAPA processes.

Preferred Skills

• Experience with Kneat template development.
• Knowledge of Kaye Validator firmware upgrades.

Key Skills

Education

Any Graduate