Downstream Drug Substance Manufacturing Associate

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

Job summary

Biocon Biologics, a global biopharmaceutical leader, seeks a Chemical Engineer to support downstream manufacturing. You will ensure GMP compliance, follow production instructions, and maintain equipment in a fast-paced biosubstance production environment.

The ideal candidate has a Bachelor's in Chemical Engineering with 1–3 years of hands-on pharma experience and strong communication and teamwork skills. On-site role based in Malaysia's Johor region.

Qualifications

• Bachelor’s degree in Chemical Engineering is mandatory.
• 1–3 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.
• Strong communication and teamwork skills.
• Good problem solving and decision making.

Responsibilities

• Monitor compliance with Good Manufacturing Practice requirements.
• Ensure production operation instructions are strictly followed.
• Update real-time data entry in Batch Manufacturing Records and related documents.
• Execute equipment qualification and validation protocols.
• Perform operations in accordance with cGMP.
• Maintain and calibrate production equipment in coordination with maintenance.
• Comply with EHS policies and procedures.
• Ensure OTIF execution for Downstream (Buffer Preparation) activities.
• Report and evaluate production deviations and investigate critical deviations.
• Ensure initial and ongoing training of Downstream personnel is carried out as needed.

Skills

Communication

Teamwork

Problem solving

Decision making

Education

Bachelor’s Degree in Chemical Engineering

Job description

Biocon Biologics, a global biopharmaceutical leader, seeks a Chemical Engineer to support downstream manufacturing. You will ensure GMP compliance, follow production instructions, and maintain equipment in a fast-paced biosubstance production environment.

The ideal candidate has a Bachelor's in Chemical Engineering with 1–3 years of hands-on pharma experience and strong communication and teamwork skills. On-site role based in Malaysia's Johor region.