2001 – Aug 2009

r, Biotech Facility)

Schering Plough Pte Ltd

(Engineering & Maintenance Engineer, Biotech Facility)

• Performed installation and operational qualification of new

process equipment such as clean steam sterilizer, dry heat

sterilizer, sterile filling machine, tray loader, capping machine,

inspection and packaging line

• Led changes/ projects related to process equipment upgrading

• Provide technical support on CQV (commissioning, qualification,and validation) activities of manufacturing equipment.

• Led investigations in process equipment deviations.

• Perform work and provide subject matter expertise on

manufacturing equipment.

• Communicate with end user on equipment issues with propose

resolution plan and corrective / preventive action (CAPA).

• Executed CAPA to prevent recurrence of equipment related

deviations.

• Implement preventive and corrective maintenance programs to

maximize equipment availability and optimize life-cycle costs.

• Led actions related to improve safety operation of process

equipment to ensure all work activities are carried out according

to site EHS procedures; and in compliance with EHS procedures /

standards.

• Liaise with process equipment manufacturers (such as GermanyBosch, Italy IMA, Finn-Aqua Ireland Steris) for ad-hoc

rectification action or upgrading projects

• Performed off-site FAT and SAT for new process equipment

• Planned preventive maintenance activities of production process

equipment

• Provide SAP (COMET) training for new employee on basic

maintenance module

• Ensure timely review of all work order, closing of maintenance

work order; initiate follow up work order and discrepancy

notification in CMMS if necessary.

• Led a team of technicians in providing engineering support to

provide timely and efficient maintenance service with safe

manner when rapid response to equipment failure is needed.

• Provide technical support on manufacturing and laboratory

equipment in timely manner.

• Ensure adequate maintenance and calibration resources are

planned and available according to end user or internal customer

expectations.

• Ensure lab and manufacturing equipment is in safe operating

environment by complying to all essential statutory requirement to

protect our employee, equipment and the environment.

• Ensure audit readiness by complying with effective standards,

regulatory / statutory and cGMP requirement to protect product

and prevent major compliance observation.

• Ensure cGMP compliance for all Product manufacturing

equipment maintenance and calibration activities

• Develop and establish equipment maintenance step,

documentation and SOP according to industry standard, good

engineering practices and OEM / vendor recommendation

• Recommend, establish and maintain the spare parts inventory

level to provide maximum equipment uptime.

Set up and qualified new process equipment

• Planned and performed routine preventive maintenance of the

production process equipment

• Support day to day production activities supports.

• Managed the engineering store for spare parts inventory

Set up and qualified new process equipment

• Planned and performed routine preventive maintenance of the

production process equipment

• Provided supports to daily production activities

• Managed the engineering store for spare parts inventory

(Maintenance Technician)

, printed circuit board

plating line

• Performed routine preventive maintenance of the production

process equipment

• Provided support in daily production activities