Senior Production Executive

Biocon; Gelang Patah; On-site; MYR 56,000 - 89,000; Full time

Benefits offered by this job

Shift allowance

Job summary

Biocon in Malaysia (Gelang Patah) is seeking a Shift Lead for Downstream-Buffer operations. You will act as the first responder to production issues, supervise the shift, ensure GMP compliance, and maintain accurate batch records and data entries.

The role requires 1–3 years of relevant experience and a Bachelor's degree in Chemical/Bioprocess/Biology or related sciences. You will coordinate maintenance with Engineering, support EHS safety practices, handle deviations (OOS/OOT), and contribute

Qualifications

• Bachelor's degree in Chemical/Bioprocess/Biology or science-related field.
• 1-3 years of experience.
• Shift requirement: Yes, 3 rotational shifts with shift allowance.
• Preferred industry: manufacturing/production.

Responsibilities

• Be the shift in charge and act as first responder to production issues.
• Supervise the shift; review batch records, logbooks and other records; guide shift personnel to GMP.
• Monitor area and documentation for GMP compliance.
• Ensure availability and real-time data entry in Batch Manufacturing Records, Checklists, Log Sheets and Equipment Cleaning Checklist.
• Prepare and execute equipment qualification and validation protocols for Buffer.
• Comply with EHS policies; ensure safety practices by all shift personnel and contractors.
• Report, evaluate and investigate production deviations, OOS or OOT.
• Plan and coordinate maintenance and calibration of buffer equipment with Engineering and Instrumentation teams.
• Ensure OTIF execution of all Downstream-Buffer activities.
• Assist with planning production schedule for unit operations.
• Data owner for process equipment used in day-to-day activity.

Skills

Shift management

GMP compliance

Batch records

Data entry

OOS/OOT reporting

Maintenance planning

Safety compliance

Education

Bachelor's in Chemical/Bioprocess/Biology

Job description

Key Responsibilities:

1. Being the shift in charge, act as a first responder to production issues and concerns


2. Supervise activities in the respective shift, review batch record, logbooks and other records, guide the shift personnel to ensure activities and records are falling in line with GMP requirement


3. To monitor area and documentation compliance with Good Manufacturing Practice


4. To ensure availability, preparation and real time data entry in Batch Manufacturing Records, Checklist, Log Sheet and Equipment Cleaning Checklist


5. To prepare and execute equipment qualification and validation protocols for Buffer


6. To comply with EHS policies and procedures. To ensure safety practices are followed by all shift personal and contract labors


7. To ensure production deviation, OOS or OOT is reported, evaluated and investigated


8. To plan and coordinate maintenance and calibration of buffer equipment with Engineering and Instrumentation team


9. Responsible for OTIF execution of all activities related to Downstream-Buffer


10. To assist with planning of production schedule for unit operations


11. Data owner for process equipment used in day-to-day activity

Qualification:

1. Bachelor's degree in Chemical/ Bioprocess/ Biology OR any Science related courses


2. Years of Experience: 1-3 years


3. Shift Requirement: Yes, 3 rotational shifts (Shift allowance is provided)


4. Preferred Industry: Any industry (manufacturing/ production industry added advantage)