Job Openings - Mersifarma

Commissioning, Qualification & Validation (CQV) Engineer

Prepare and review URS, DQ, and CQV strategies for new systems and equipment.
Develop IQ/OQ/PQ, commissioning, and risk assessment protocols.
Perform and monitor qualification of HVAC, utilities, and process equipment.
Prepare qualification reports and verify test results.
Coordinate with QA, Production, and Vendors.
Supervise FAT and SAT activities.
Support Process Validation, Cleaning Validation, and CSV activities.
Support the development of VMP and related SOPs.
Maintain qualified systems in a validated state through requalification, periodic review, and change control.

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Industrial Engineering, Pharmacy, Biotechnology, or a related field.
Minimum 2 years of experience in CQV, preferably within the pharmaceutical, biotechnology, or sterile manufacturing industry.
Good understanding of CPOB, PIC/S, ICH, WHO GMP, and validation principles.
Familiar with preparing and executing IQ/OQ/PQ and Commissioning protocols.
Familiar with URS, P&ID, and other technical documentation.
Strong attention to detail, analytical skills, and documentation skills.
Good communication and coordination skills.
Proficient in Bahasa Indonesia and English.
Mandarin proficiency is an advantage.
Willing to be placed at Biovac (Mersifarma Group), Plant – Sukabumi, West Java.