Technical Lead

Job Description

Provide Change Control and CAPA (Corrective Action Preventative Action) support which may include assessment, verification studies (e.g., heat penetration) and execution of validation protocols, subsequent reports writing regarding thermal validation activities for equipment such as autoclave/sterilizers, Isolator, Tunnel, Oven, Vial Washer, Process Skid SIPs, Biowaste System, Decontamination Autoclave, Sanitization system.

Perform Thermal validation activities may include but not limited to Review of Design documents, Development of validation plan, IQ (Installation Qualification) / OQ (Operational Qualification)/PQ (Performance Qualification) protocol preparation/execution and report writing, Non-conformance/Deviation investigation, Cycle Development or ranking studies of equipment such as Autoclaves, Process system SIP, Isolator, Oven, Tunnel, Vial Washer, Decontamination Autoclave, Sanitization System, Biowaste System.

Documentation support/ Schedule Coordination is required to ensure compliance and adherence to project schedules.

Documentation support includes but is not limited to Change Control Initiation/ support/review, SOPs (Standard Operating Procedures) or Work Instructions creation/revision, preparation of standalone technical assessments, Item diagram review, generation/review of PM (Preventative Maintenance) Task list, template/supplement update or creation, etc.

Support manufacturing through startup/feasibility, decommissioning, breakdowns, or troubleshooting as needed.

Participate in FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and Critical Test plan execution when required.

Attend/Initiate different meetings with stakeholders (Operations, Manufacturing Technology, Engineering Technical Services, Quality) and act towards deliverables.

Support inspection activities for projects and provide technical input.

Support projects such as Support studies, Kaye Validator Firmware upgrade, Temperature Control Unit qualification, Kneat template Development for Performance Qualification or requalification protocols/reports, SOP development/update, etc