Engineering plays a vital role in ensuring that our manufacturing equipment, laboratories, facilities, and utility systems operate reliably and in compliance with regulatory requirements. By joining our Engineering team as a Calibration Specialist, you will help maintain the accuracy, integrity, and compliance of instruments and equipment that support the manufacture and testing of medicines.
Your technical expertise, attention to detail, and commitment to quality will help ensure that calibration activities are completed safely, accurately, and on schedule. Through close collaboration with Manufacturing, Packaging, Quality Control, Technical Services, Warehouse, and external service providers, you will contribute to reliable operations and help ensure that patients receive the medicines they need.
What You Will Achieve
In this role, you will:
- Perform calibration activities for instruments and equipment across Manufacturing, Packaging, Laboratory, Quality Control, Technical Services, and Warehouse areas at the Jakarta site.
- Execute calibration activities in accordance with approved procedures, established schedules, applicable regulatory requirements, and Pfizer quality standards.
- Prepare, execute, and document calibration protocols, periodic reviews, and final reports accurately and within the required timelines.
- Maintain calibration schedules and equipment records using the Computerized Maintenance Management System or Enterprise Asset Management System.
- Coordinate calibration schedules and activities with Manufacturing, Quality, Engineering, Technical Services, Warehouse, and other relevant departments.
- Support equipment qualification, validation, commissioning, and related technical activities in collaboration with the Technical Services and Engineering teams.
- Support the maintenance and verification of manufacturing equipment, laboratory equipment, and cleanroom systems, including HEPA filter integrity testing, air change rate measurement, and air balancing.
- Support the development, implementation, and maintenance of calibration procedures, records, and other controlled documentation.
- Ensure calibration documentation is complete, accurate, traceable, and compliant with current Good Manufacturing Practices and Data Integrity requirements.
- Support the timely execution and closure of Corrective and Preventive Actions, change requests, and other quality commitments related to calibration activities.
- Coordinate with qualified external vendors for outsourced calibration services and the purchase, repair, or replacement of instruments.
- Follow up on the review and approval of documents associated with calibration activities.
- Participate as an auditee and provide the required documentation and technical explanation during regulatory, internal, customer, BPOM, and global audit activities.
- Maintain compliance with Pfizer Quality, Environmental Health and Safety, and regulatory requirements while performing all assigned activities.
- Contribute to continuous improvement initiatives that enhance calibration effectiveness, equipment reliability, compliance, and operational efficiency.
- Organize assigned activities, manage priorities, and deliver individual commitments within agreed timelines.
Here Is What You Need (Minimum Requirements)
- Bachelor’s degree in Automation, Control or Electrical Engineering. Mechanical Engineering, or another relevant engineering discipline with related experienced are welcome to apply
- Basic knowledge of current Good Manufacturing Practices, Data Integrity principles, and Environmental Health and Safety requirements.
- Understanding of instrument calibration principles and practices.
- Basic understanding of equipment validation and qualification processes within the pharmaceutical or another regulated industry.
- Ability to follow approved procedures and prepare clear, accurate, and traceable technical documentation.
- Demonstrated computer and technical skills, including the ability to maintain electronic equipment records and schedules.
- Effective problem-solving skills and the ability to identify and escalate calibration or equipment-related issues.
- Good interpersonal, verbal, and written communication skills.
- Ability to collaborate effectively with cross-functional teams and external service providers.
- Ability to organize work, manage priorities, and complete assigned commitments within established timelines.
Bonus Points If You Have (Preferred Requirements)
- Experience performing calibration activities in the pharmaceutical, biopharmaceutical, medical device, or another regulated manufacturing industry.
- Experience working in a current Good Manufacturing Practices environment.
- Knowledge of calibration standards, measurement principles, instrument traceability, and calibration documentation.
- Experience using a Computerized Maintenance Management System or Enterprise Asset Management System to schedule and document calibration activities.
- Experience supporting equipment qualification, validation, commissioning, or periodic review activities.
- Experience supporting HEPA filter integrity testing, air change rate measurement, cleanroom testing, or air balancing activities.
- Experience supporting investigations, Corrective and Preventive Actions, change controls, and audit commitments.
- Experience coordinating calibration activities with external contractors or equipment vendors.
- Experience participating in regulatory, customer, or internal audits.
- Strong organizational skills and attention to detail.
- Ability to work independently while collaborating effectively as part of a cross-functional team.
- A proactive, accountable, and continuous improvement mindset.
- Ability to adapt priorities in response to operational and business requirements.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Engineering