Biopharma Upstream Process Operations Executive

Biocon; Johor Bahru; On-site; MYR 112,000 - 167,000; Full time

Benefits offered by this job

Medical insurance

Dental coverage

Life insurance

Gym facilities

Annual leave

Job summary

Biocon Malaysia is seeking an Executive for Biopharma Drug Substance Upstream to execute process operations and monitor batch performance in the plant. The role emphasizes GMP/EHS compliance, real-time BMR updates, and coordination with Engineering for equipment maintenance.

The candidate should have 4–11 years of hands-on biopharma experience and a Bachelor's degree in Biotechnology, Chemical Engineering, Bioprocess, Biochemistry, or equivalent.

Qualifications

• Bachelor's degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent.
• 4–11 years hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.
• Knowledge of GMP and EHS requirements.

Responsibilities

• Execute process operations and monitor batch performance per plant procedures.
• Ensure compliance with GMP and EHS requirements.
• Follow production instructions and maintain real-time records (BMRs).
• Coordinate with Engineering/Maintenance for equipment upkeep.
• Report Non-Conformities, investigate, and implement CAPA.
• Maintain process equipment and facilities within scheduled timelines.
• Plan raw materials and manage SAP-based inventory.
• Support Qualification and Validation activities and commissioning tasks.
• Prepare and revise necessary production documents as required.
• Manage process orders and inventory in SAP.

Skills

Process operations

Batch monitoring

GMP compliance

Documentation control

SAP experience

Excel proficiency

Education

Bachelor's Degree in Biotechnology or related field

Tools

SAP

Excel

Job description

Biocon Malaysia is seeking an Executive for Biopharma Drug Substance Upstream to execute process operations and monitor batch performance in the plant. The role emphasizes GMP/EHS compliance, real-time BMR updates, and coordination with Engineering for equipment maintenance.

The candidate should have 4–11 years of hands-on biopharma experience and a Bachelor's degree in Biotechnology, Chemical Engineering, Bioprocess, Biochemistry, or equivalent.