Associate & Senior Associate - Dispatch & Solvent Recovery (Drug Substance)

Biocon Biologics Limited; Johor Bahru; On-site; MYR 42,000 - 72,000; Full time

Job summary

Biocon Biologics Limited in Malaysia seeks a hands‑on chemical/process engineer to join our biopharmaceutical operations. You will handle qualification/validation, SOP execution, and Solvent Recovery Plant processes to ensure compliance and product quality.

The role involves data entry in quality records, calibration and maintenance of plant equipment, and adherence to cGMP and EHS requirements. Candidates should hold a bachelor’s degree in chemical engineering, chemistry, biochemistry or

Qualifications

• Bachelor’s degree in chemical engineering, Chemistry, Biochemistry or equivalent field.
• 1 - 6 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.

Responsibilities

• Prepare and execute qualification/validation and study activities.
• Perform activities per SOPs and Equipment Operating Procedures with ALCOA principles.
• Prepare and maintain documents related to Solvent Recovery Plant operations.
• Perform and monitor activities related to cGMP and EHS.
• Data entry in quality records.
• Comply with pollution control and safety requirements (EHS).
• Report non-conformities and implement corrective/preventive actions.
• Ensure calibration and preventive maintenance of Solvent Recovery Plant storage tanks, equipment, and accessories.
• Ensure calibration of pH sensors.
• Perform in-process product sampling, inspection and storage per SOPs.
• Schedule preventive maintenance of Solvent Recovery Plant equipment in coordination with Engineering Maintenance and Instrumentation Automation.

Education

Bachelor’s degree in chemical engineering, Chemistry, Biochemistry or equivalent field

Job description

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

https://www.bioconbiologics.com

Roles and Responsibilities

• To prepare and execute qualification/ validation and study activities.
• To perform all activities as per Standard Operating Procedures and Equipment Operating Procedures along with ALCOA principles.
• To prepare and maintain documents or record related to Solvent Recovery Plant operations.
• To perform and monitor all activities related to cGMP and EHS.
• To perform data entry in quality records.6.
• To comply with pollution control and safety requirements as per the policies of the organisation pertaining to EHS.
• To report all non-conformities and implementation of corrective / preventive actions in specific areas of operation.
• To ensure calibration and preventive maintenance of Solvent Recovery Plant’s Storage Tanks, Equipment and Accessories.
• To ensure calibration of pH sensors.
• To perform in-process product sampling, inspection and storage as per Standard Operating Procedures.
• To schedule preventive maintenance of Solvent Recovery Plant’s Equipment in coordination with Engineering Maintenance and Instrumentation Automation Department.
• Authorized to raise deviation reports, deviation requests, and change controls related to Solvent Recovery Plant.
• Bachelor’s degree in chemical engineering, Chemistry, Biochemistry or equivalent field.
• 1 - 6 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations