GMP Qualification Engineer — Validation & Compliance

Pfizer; Pulau Untung Jawa; In loco; IDR 180.000.000 - 320.000.000; Tempo pieno

Descrizione del lavoro

Pfizer Indonesia is seeking a Qualification/Validation professional to ensure equipment, utilities, facilities, HVAC, and environmental-control systems are qualified, compliant, and audit-ready. You will coordinate commissioning, IQ/OQ, and validation activities with Quality, Validation, Production, and Engineering teams, supporting audits and change controls.

The role requires a Diploma 3 or higher in a relevant technical field, at least 2 years of related experience, and strong documentation,

Competenze

• 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 read and understand technical specifications, drawings, P&IDs, layouts, operating principles, and system boundaries.
• Ability to prepare clear technical documents, maintain traceability, and organize qualification records for review and approval.
• Strong analytical, organizational, communication, teamwork, and problem‑solving skills.
• Proficiency in Microsoft Office applications and the ability to work with electronic document, change-control, or maintenance systems as assigned.

Mansioni

• Plan, coordinate, execute, document, review, and close commissioning, qualification, requalification, and decommissioning activities for equipment, utilities, facilities, HVAC, cleanrooms, 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.

Conoscenze

Analytical

Organizational

Communication

Teamwork

Problem-solving

Formazione

Diploma 3 (D3) or higher in Mechanical Engineering, Electrical Engineering, Automation, Mechatronics, or related

Strumenti

Microsoft Office

Descrizione del lavoro

Pfizer Indonesia is seeking a Qualification/Validation professional to ensure equipment, utilities, facilities, HVAC, and environmental-control systems are qualified, compliant, and audit-ready. You will coordinate commissioning, IQ/OQ, and validation activities with Quality, Validation, Production, and Engineering teams, supporting audits and change controls.

The role requires a Diploma 3 or higher in a relevant technical field, at least 2 years of related experience, and strong documentation,