Qualification Engineer

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

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.

What You Will Achieve

• 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.

Here Is What You Need (Minimum Requirements)

• 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 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.

Bonus Points If You Have (Preferred Requirements)

• Experience in the pharmaceutical industry or another regulated manufacturing environment.
• Hands‑on qualification experience with manufacturing equipment, utilities, HVAC, cleanrooms, water systems, compressed gases, automation, or facility systems.
• Experience supporting FAT, SAT, commissioning, project handover, requalification, periodic review, and qualification lifecycle management.
• Experience coordinating contractors, consultants, original equipment manufacturers, testing laboratories, calibration providers, and cross‑functional project teams.
• Experience supporting audits, regulatory inspections, quality assessments, technical investigations, or CAPA effectiveness verification.
• Additional training or certification in qualification/validation, risk management, project management, GMP, data integrity, or EHS.
• Curiosity and responsible use of common AI tools, including generative technologies such as Microsoft Copilot, to support problem solving, document quality, and productivity while protecting confidential and regulated information.

How You Will Work

Decisive: Make timely, risk‑based decisions and promptly escalate qualification, quality, safety, technical, documentation, or schedule concerns.Focused: Prioritize critical deliverables, maintain accurate records, and complete agreed actions on time.Connected: Collaborate effectively across Quality, Validation, Production, Maintenance, Utility, Facility, Engineering, EHS, and external partners.Courageous: Raise compliance, data‑integrity, technical, and safety concerns directly and act consistently with approved procedures.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI‑use guidelines available onPfizer Careers.

Pfizer is a leading research‑based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place, as well as some of the world’s best‑known consumer healthcare brands.

For more than 150 years, Pfizer has worked to make a difference for all who rely on us. Every day, our colleagues work in developed and emerging markets to treat, cure and eradicate life‑threatening conditions and challenge some of the most feared diseases of our time. Pfizer also collaborates with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world.

To learn more, visit www.pfizer.com.

For additional information on our guidelines, please visit http://www.pfizer.com/community-guidelines.

Pfizer is a leading research‑based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place, as well as some of the world’s best‑known consumer healthcare brands.

For more than 150 years, Pfizer has worked to make a difference for all who rely on us. Every day, our colleagues work in developed and emerging markets to treat, cure and eradicate life‑threatening conditions and challenge some of the most feared diseases of our time. Pfizer also collaborates with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world.

To learn more, visit www.pfizer.com.

For additional information on our guidelines, please visit http://www.pfizer.com/community-guidelines.