5 дней назад
Calibration Specialist (Pharmaceutical Manufacturing)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Calibration Specialist (Pharmaceutical Manufacturing): Performing and documenting calibration activities for manufacturing, laboratory, cleanroom, and utility equipment at the Jakarta site with an accent on regulatory compliance, data integrity, and equipment reliability. Focus on supporting qualification and validation, maintaining traceable records, coordinating external vendors, and preparing for audits.
Location: Jakarta, Indonesia; onsite at the Jakarta manufacturing site
Company
operates a pharmaceutical manufacturing and testing environment supported by Engineering, Manufacturing, Quality Control, Technical Services, Packaging, and Warehouse teams.
What you will do
- Perform calibration activities for instruments and equipment across manufacturing, packaging, laboratory, quality control, technical services, and warehouse areas.
- Prepare, execute, and document calibration protocols, periodic reviews, final reports, schedules, and equipment records.
- Maintain calibration data in a Computerized Maintenance Management System or Enterprise Asset Management System.
- Support equipment qualification, validation, commissioning, maintenance, and verification activities, including HEPA filter integrity testing, air change rate measurement, and air balancing.
- Coordinate calibration work with cross-functional departments and qualified external service providers.
- Support corrective and preventive actions, change requests, audits, continuous improvement, and compliance with Quality, Environmental Health and Safety, regulatory, current Good Manufacturing Practices, and Data Integrity requirements.
Requirements
- Bachelor’s degree in Automation, Control, Electrical, Mechanical, or another relevant engineering discipline.
- Understanding of instrument calibration principles and practices.
- Basic knowledge of current Good Manufacturing Practices, Data Integrity, Environmental Health and Safety, and equipment qualification and validation processes.
- Ability to prepare clear, accurate, traceable technical documentation and maintain electronic equipment records and schedules.
- Problem-solving, communication, organization, and prioritization skills.
- Ability to collaborate with cross-functional teams and external service providers while completing commitments within established timelines.
Nice to have
- Calibration experience in pharmaceutical, biopharmaceutical, medical device, or other regulated manufacturing environments.
- Knowledge of calibration standards, measurement principles, instrument traceability, and calibration documentation.
- Experience with equipment qualification, validation, commissioning, periodic reviews, investigations, corrective and preventive actions, change controls, or audit commitments.
- Experience with cleanroom testing, HEPA filter integrity testing, air change rate measurement, or air balancing.
- Experience coordinating calibration activities with contractors and equipment vendors.
Culture & Benefits
- Cross-functional collaboration with Manufacturing, Packaging, Quality Control, Technical Services, Warehouse, Engineering, and external providers.
- Work focused on equipment reliability, patient safety, regulatory compliance, and operational efficiency.
- Equal opportunity employment in accordance with applicable legislation.
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