Qualification Engineer

Pfizer; Pulau Untung Jawa; Vor Ort; IDR 180.000.000 - 320.000.000; Vollzeit

Zusammenfassung

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,

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Analytical

Organizational

Communication

Teamwork

Problem-solving

Ausbildung

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

Tools

Microsoft Office

Jobbeschreibung

Use Your Power for Purpose

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.

• Maintain complete, accurate, traceable, retrievable, and audit-ready records in accordance with Good Documentation Practices, ALCOA+ principles, and record-retention requirements.

Here Is What You Need (Minimum 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.
  Work Location Assignment:On Premise

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 on Pfizer Careers.

Engineering