GMP Qualification Engineer — Validation & Compliance

Pfizer Indonesia; Jakarta Utara; On-site; IDR 144,000,000 - 216,000,000; Full time

Job summary

Pfizer Indonesia is seeking a Qualification/Validation professional to ensure equipment, utilities, and facilities stay qualified, compliant, and audit-ready. You will work with Quality, Validation, Production, and Engineering to translate technical requirements into disciplined execution and robust records.

The role emphasizes IQ/OQ/PQ protocol development, change control coordination, and close collaboration with cross-functional teams to support lifecycle management and continuous

Qualifications

• Diploma 3 (D3) or higher in Mechanical, Electrical, Automation, Mechatronics, or related discipline.
• At least 2 years of experience in qualification, validation, commissioning, or related technical activities.
• Knowledge of GMP, ALCOA+, data integrity, Change Control, deviations, CAPA, and inspection readiness.
• Ability to prepare IQ, OQ protocols and reports, and support PQ activities.
• Ability to read and understand technical specifications, drawings, P&IDs, layouts, and system boundaries.
• Strong analytical, organizational, communication, teamwork, and problem-solving skills.

Responsibilities

• Plan, coordinate, execute, document, review, and close qualification activities for equipment, utilities, HVAC, cleanrooms, and systems.
• Prepare and maintain lifecycle documents, IQ/OQ/ PQ protocols and reports, and traceability records.
• Support field testing, system acceptance testing, and resolution of discrepancies and punch-list items.
• Coordinate qualification‑related Change Controls and assess impacts from repairs, changes, or upgrades.
• Support engineering projects from concept to closeout and participate in design reviews and FAT/SAT activities.
• Review technical specs, certificates, test records, and turnover packages against requirements and GMP expectations.

Skills

GMP knowledge

Documentation

Change Control

IQ/OQ protocols

PQ support

Reading drawings

Technical writing

Analytical skills

Communication

Teamwork

Education

D3 or higher

Mechanical/Electrical/Automation

Tools

Maintenance systems

Document management systems

Job description

Pfizer Indonesia is seeking a Qualification/Validation professional to ensure equipment, utilities, and facilities stay qualified, compliant, and audit-ready. You will work with Quality, Validation, Production, and Engineering to translate technical requirements into disciplined execution and robust records.

The role emphasizes IQ/OQ/PQ protocol development, change control coordination, and close collaboration with cross-functional teams to support lifecycle management and continuous