Biopharma Process Operator - GMP & Downstream

Biocon Biologics Limited; Johor Bahru; On-site; MYR 60,000 - 90,000; Full time

Job summary

Biocon Biologics Limited is hiring for a production support role focusing on GMP compliance and data integrity. You will ensure adherence to cGMP, maintain accurate production records, and support equipment qualification and validation activities.

The role requires a relevant Bachelor's degree and 1–4 years of hands-on experience in biopharmaceutical manufacturing, with annual cGMP training and data documentation duties.

Qualifications

• Bachelor’s degree in biotechnology, Chemical Engineering, or equivalent field.
• 1–4 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.
• Mandatory cGMP or GxP training and compliance.

Responsibilities

• Monitor compliance with Good Manufacturing Practice requirements.
• Ensure production operation instructions are strictly followed.
• Update real-time data entry in DSP2 and related documents (BMR, CKL, LS, ECC).
• Execute equipment qualification and validation protocols.
• Perform operations in accordance with cGMP and coordinate with maintenance for equipment upkeep.

Skills

GxP awareness

cGMP knowledge

Documentation

Data integrity

Basic microbiology

Education

Bachelor's degree in biotechnology or Chemical Engineering or equivalent

Tools

DSP2 data systems

GxP documentation tools

Job description

Biocon Biologics Limited is hiring for a production support role focusing on GMP compliance and data integrity. You will ensure adherence to cGMP, maintain accurate production records, and support equipment qualification and validation activities.

The role requires a relevant Bachelor's degree and 1–4 years of hands-on experience in biopharmaceutical manufacturing, with annual cGMP training and data documentation duties.