Associate/Senior Associate - Chemical Engineering

Roles and Responsibilities:

• Lead the commissioning and qualification of equipments, ensuring compliance with all engineering and regulatory standards.

• Coordinate with cross-functional teams including project management, QA, and validation to ensure timely execution and compliance.

• Prepare and maintain detailed documentation including protocols, reports, and change controls related to utility systems

• Ensure all systems are commissioned in line with GMP, FDA, and other applicable regulatory guidelines.

• Uphold strict adherence to EHS standards during all utility commissioning and operational activities.

• To carry out planned preventive maintenance on all electrical panels, equipment and its accessories aiming to achieve maximum plant availability with a target of zero unplanned downtime.

• To maintain availability of spare part of all equipment at all time and ensure no downtime due to non-availability spare part.

• To respond, carry out and record equipment maintenance activity effectively and efficiently.

• Observation and rectification of equipment/ machines condition and detection of unusual conditions in a proactive manner.

• Ensure all equipment is operated and maintained as per manufacturers recommendation.

• Familiarization with the manufacturing process and related equipment.

• To communicate with external vendor for site services/ repair.

• Daily reporting of activities and updating any issues at work to the superior.

• Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ.

• To attend, record and conduct all trainings required as per training matrix/ schedule.

• Generate various document procedure/protocol/report as and when required.

• Fill log sheets/ checklist/ history card/ planner as described in the SOPs.

• Follow the established procedures and policies of the company.

• Participate in project activity on process optimisation, facility upgrade, or objective.

• To propose objectives and targets on work area and comply to set timeline.

• Participate in cost and energy management program.

• On routine basis to provide improvement proposal on equipment, process, or quality system.

• Responsible for data management, trending and periodic presentation.

• To prepare shift scheduling.

• To plan and prepare preventive maintenance activity/schedule.

• To evaluate on vendor performance/ quality/ capability - vendor evaluation/ management process. 

Information :

• Company : Biocon
• Position : Associate/Senior Associate - Chemical Engineering
• Location : Johor
• Country : MY