Qualification Engineer — GMP & Validation Specialist

Pfizer; Jakarta Pusat; On-site; IDR 133,920,000 - 200,880,000; Full time

Job summary

Pfizer Indonesia seeks a Qualified Validation Specialist to ensure equipment, utilities, and facilities stay compliant and audit-ready. You will collaborate with Quality, Validation, Production, Maintenance, and Engineering to turn requirements into disciplined execution and complete qualification records.

You will manage commissioning, qualification, and decommissioning activities, prepare lifecycle documents, and support IQ/OQ/PQ.

Qualifications

• Diploma 3 or higher in Mechanical, Electrical, Automation, Mechatronics, or a related field.
• At least 2 years in qualification, validation, commissioning, engineering compliance, or related activities.
• Working knowledge of GMP, 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.

Responsibilities

• Plan, coordinate, and close commissioning, qualification, requalification, and decommissioning activities.
• Prepare and maintain lifecycle documents including user requirements, design reviews, risk assessments, and qualification reports.
• Execute IQ/OQ and support PQ activities with system owners and technical functions.
• Coordinate change controls and assess qualification impacts from repairs, maintenance, replacements, relocations, or software changes.
• Lead field verification, testing, discrepancies, punch-lists, deviations, and CAPA follow-up.
• Support engineering and capital projects from concept to closeout, including handover and validation readiness.
• Participate in design reviews, FAT/SAT, and turnover packages; maintain qualification-readiness reviews.
• Maintain qualification-status tracking and periodic requalification planning.
• Assist investigations, deviations, CAPA, and effectiveness verification.
• Develop and update SOPs, work instructions, forms, and technical procedures.

Skills

GMP knowledge

Data integrity

Documentation skills

Analytical skills

Communication skills

Education

Diploma 3 in Mechanical/Electrical/Automation/Mechatronics

Tools

Microsoft Office

Document management systems

Job description

Pfizer Indonesia seeks a Qualified Validation Specialist to ensure equipment, utilities, and facilities stay compliant and audit-ready. You will collaborate with Quality, Validation, Production, Maintenance, and Engineering to turn requirements into disciplined execution and complete qualification records.

You will manage commissioning, qualification, and decommissioning activities, prepare lifecycle documents, and support IQ/OQ/PQ.