Engineer Drug Substance (Upstream & Downstream)

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.