Qualification Engineer

Your work will help ensure that manufacturing equipment, utilities, facilities, environmental-control systems, and other systems remain qualified, compliant, safe, and ready to support the reliable supply of medicines. By working closely with Quality, Validation, Production, Maintenance, Utility, Engineering, EHS, and external partners, you will turn technical requirements into disciplined execution and complete, audit-ready qualification records.

• Plan, coordinate, execute, document, review, and close commissioning, qualification, requalification, and decommissioning activities for equipment, utilities, facilities, HVAC, clean rooms, automation, and environmental-control systems.
• Prepare, review, execute, and maintain lifecycle documents including user requirements, design reviews, impact and risk assessments, qualification plans, commissioning protocols and reports, IQ/OQ protocols and reports, traceability records, and qualification summary reports.
• Execute Installation Qualification and Operational Qualification, and support Performance Qualification with System Owners, Production, Quality, Validation, and relevant technical functions.
• Initiate and coordinate qualification‑related Change Controls, define required deliverables, and assess qualification impacts arising from repairs, maintenance, component replacement, relocation, software or automation changes, upgrades, and modifications.
• Coordinate field verification, challenge testing, commissioning testing, system acceptance testing, and timely resolution of discrepancies, observations, punch‑list items, deviations, and corrective actions.
• Support engineering and capital projects from concept and design through installation, commissioning, qualification, operational handover, and closeout.
• Participate in design reviews, vendor site surveys, FAT, SAT, construction walkthroughs, system inspections, pre‑installation assessments, and qualification‑readiness reviews.
• Review and verify technical specifications, certificates, test records, drawings, P&IDs, layouts, as‑built drawings, FAT/SAT records, and turnover packages against approved requirements, GMP expectations, and safety controls.
• Maintain qualification‑status tracking, support periodic review and requalification planning, monitor due dates, and elevate overdue or at‑risk activities.
• Support technical investigations, deviations, root‑cause analysis, CAPA development and implementation, and effectiveness verification when qualification or engineering expertise is required.
• Develop and update qualification‑related SOPs, work instructions, job aids, forms, and technical procedures.
• Confirm operational‑readiness prerequisites, including maintenance, calibration, training, spare parts, operating procedures, drawings, and documentation, before system release.
• Prepare supporting information and participate in GEMBAs, internal and external audits, regulatory inspections, quality assessments, and compliance reviews.

• Maintain complete, accurate, traceable, retrievable, and audit‑ready records in accordance with Good Documentation Practices, ALCOA+ principles, and record‑retention requirements.
• Diploma 3 (D3) or higher qualification in Mechanical Engineering, Electrical Engineering, Automation, Mechatronics, or another relevant technical discipline.
• At least 2 years of relevant experience in qualification, validation, commissioning, engineering compliance, or related technical activities.
• Working knowledge of GMP, Good Documentation Practices, data integrity, Change Control, deviations, CAPA, and inspection readiness.
• Ability to prepare and execute commissioning, IQ, and OQ protocols and reports, and to support PQ activities.
• Ability to…