The ideal candidate will possess at least 5 to 7 years of technical expertise in process engineering coupled with exceptional project management skills in Pharma or medical device industry preferably. Proven experience in process engineering within a manufacturing environment, with a minimum of 5 years of relevant experience. At least 1 ~ 3 years of hands-on experience in cGMP and GDP as well as validation requirement, product development, technical troubleshooting is preferred. Demonstration of excellent written scientific communications skills. The successful candidate will play a crucial role in optimizing our manufacturing processes, improving efficiency, and ensuring quality standards are met.
Required technical expertise to assess current manufacturing processes, identify inefficiencies, and develop innovative solutions to optimize manufacturing operations.
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Monitor and follow up on production process closely, ensure that production departments follow schedule, manufacture high-quality products to meet customer specifications in a timely mannger
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To design the test protocol and lead the process validation (IQ, OQ, PQ).
Provide training and support to manufacturing personnel on current/new processes, equipment, and tools. Conduct training sessions, create training materials, and ensure that operators are knowledgeable about and follow established procedures.
Identify and mitigate process-related risks that may impact product quality, safety, or compliance. Collaborate with the risk management team to implement risk assessment and mitigation strategies.
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Participate in all aspects of product development process including specifications, requirements definition, design and implementation, ensuring that they meet company and industry standard and codes.
Reads and understands orthographic (2D) and/or isometric (3D) designs and manufactures drawings.
On-site service calls, outsource & helpdesk support for Singapore & Malaysia.
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Coordinate, arrange and plan new grade trial run with R&D and Operation team, and handle the trial run and the evaluation.
Evaluate process performance and key process parameters from long term view and/or periodically to uncover potential risk that may leads to Plant instability, Safety or Quality issues
Troubleshoot plant trouble related to process, perform root cause analysis and propose corrective and preventive measures as process engineering function and/or based on request basis
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QHSE Responsibility: Comply with SLB QHSE (Quality, Health, Safety, Environment) policies and Standards; Comply with government laws and regulations on Quality, Health, Safety, and Environment;
Accountable for adhering to company policies, standards, procedures, and work instructions within area of activity.
Actively looking for improvement opportunities in day-to-day business processes
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QHSE Responsibility: Comply with SLB QHSE (Quality, Health, Safety, Environment) policies and Standards; Comply with government laws and regulations on Quality, Health, Safety, and Environment;
Accountable for adhering to company policies, standards, procedures, and work instructions within area of activity.
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