Engineer Drug Substance (Upstream & Downstream)

Biocon Biologics; Gelang Patah; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading biopharmaceutical company is hiring for various levels of production roles in Gelang Patah, Johor. Candidates with degrees in Bio-Medical/Chemical Engineering or related fields are encouraged to apply. Responsibilities include monitoring compliance with GMP, maintaining production equipment, and data management in the SAP system. The role requires knowledge of cleanroom operations and the ability to work in rotating shifts. A strong background in biopharma manufacturing is preferred.

Qualifications

• Candidates should have relevant experience in biopharma or pharmaceutical manufacturing.
• Knowledge of compliance with Good Manufacturing Practices (GMP) is essential.
• Open to work in rotating shifts and must prioritize location in Johor.

Responsibilities

• Monitor batch performance and process operations as per standard procedures.
• Maintain compliance with Good Manufacturing requirements.
• Update production records and manage inventory through SAP.

Skills

Knowledge of GMP

Cleanroom operations

Mammalian cell culture

Purification processes

Education

Bachelor's in Bio-Medical / Chemical Engineering

Master's or PhD in Bioprocess / Microbiology / Biotechnology

Tools

SAP

Job description

Job Descriptions (Upstream)

1. To execute the process operations and monitor the batch performance as per standard procedures in the plant.
2. To practice and monitor the compliance with the requirements of Good Manufacturing.
3. To execute the instructions relating to production operations.
4. Follow the established procedures and policies of the company pertaining to EHS management system and compliance.
5. To update the BMRs and other production records at real time.
6. Maintenance and utilization of raw materials as per production requirement.
7. To report all deviations to higher levels.
8. To ensure timely maintenance of production premises and equipment in co‑ordination with Engineering department.
9. To follow timely and effective communication and report process and facility related issues to appropriate higher levels.
10. To execute Qualification and Validation protocols as per plan.
11. To participate in Commissioning and Qualification activities.
12. To prepare and revise necessary documents as and when required.
13. Responsible for Process order and Inventory management in SAP system.
14. Data owner for process equipment used in day‑to‑day activity.

Job Descriptions (Downstream)

1. To monitor the compliance with the requirements of Good Manufacturing Practice.
2. To ensure the instructions relating to production operations are strictly followed.
3. To update the real time data entry in BMR'S, CKL, LS, ECC and other documents in DSP2.
4. To execute equipment qualification protocols and validation protocols.
5. To perform and document operations in accordance with cGMP.
6. Maintenance of Production equipment in co‑ordination with maintenance department.
7. To comply with EHS policies and procedures.
8. Responsible for OTIF execution of all the activities related to Downstream Purification-2.
9. Data owner for process equipment used in day‑to‑day activity.

Qualifications

Candidates with Bachelor's, Master's, or PhD in:

• Bio‑Medical / Chemical Engineering
• Bioprocess / Microbiology / Biotechnology

We are hiring across levels

Trainee | Junior Executive | Executive | Senior Executive | Assistant Manager | Manager

Focus Areas

Upstream & Downstream Manufacturing | Buffer Preparation | Process Engineer (PE)/ MSAT/ QMS

Eligibility Criteria

• Malaysian candidates with relevant experience in biopharma / pharmaceutical / biotechnology manufacturing.
• Knowledge of GMP, biologics, cleanroom operations, mammalian cell culture, purification is an added advantage.
• Priority for candidates able to work in Johor.
• Must be open to work in rotating shifts.