Senior Engineer – Process Engineering (Biologics, Tuas, Established MNC) - #1087422

This role requires highly cross functional interactions with key site functions to ensure success in production and release performance. Individual must be able to effectively communicate and collaborate closely with the team members and various SME to ensure equipment are operational to sustain daily operations, resolve operation challenges and implement effective measures to address the challenges to ensure without compromising on safety and compliance.

Location: Tuas

Salary up to $10000

1 Year Contract

Design & Project Engineering:

• Support NPI and Site projects as Engineering Technical Lead or Subject matter experts for process equipment
• Provide technical expertise in site selection assessment to identify equipment/facility gaps, select new equipment, assess layout/utilities capacity and partner project managers to develop project cost and schedule.
• Lead F&E to participate in technical transfer activities and cross-functional meetings.
• Work independently and/or with project managers to complete engineering projects of various scales within schedule, budget and quality constraints.
• Effectively manage and work with project CQV team to ensure timely delivery of projects.
• Prompt updates or escalation of issues and challenges
• Responsible for commissioning and qualification activities including FAT, SAT, PSSR, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment.
• Participate in the system walk-down, ensure the closure of punch items and support the takeover of the system from the project team
• Work closely with project managers to introduce new equipment including development of business case, project charter, user requirement specifications, quality risk assessments, conceptual design, preliminary design, design specifications and detail design.
• Participate in design review and setup up of new asset and associated maintenance plan/spares in Maximo.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.

Daily Operations

• Accountability and ownership of assigned equipment
• Subject matter expert for process equipment performance and operation to ensure safety, compliance and sustained operation
• Effectively communicate and collaborate with cross function stakeholders to address operational challenges and concerns to ensure sustained operation and minimal interruptions to operations activities.
• Lead and participate in equipment breakdown investigations to identify root causes. Effectively communicate to the customers on the subsequent plans, short term, and long-term mitigating actions.
• Collaborate closely with cross functional SME to implement effective corrective, preventive action and improvements to eliminate or mitigate future recurrence.
• Ensure operation continuity through asset lifecycle management planning, assess and identify impact to safety, compliance, operational schedule and cost.
• Perform assessment for equipment during new product introduction, change controls and other qualifications activities to ensure equipment are in its validated state.
• Accountable for deviation/change control associated to process equipment performance.
• Responsible for investigation of deviations, development of corrective and preventive actions
• and implementation of change controls in a timely manner.
• Support equipment readiness initiatives for New Product Introduction or Product Campaign Changeover
• Responsible for operation and reliability of Biotechnology process equipment and/or single use systems assigned.
• Apply process equipment knowledge to perform troubleshooting of equipment failures/malfunctions and the development of technical assessments during normal working hours and after hours when required.
• Develop, implement and optimize maintenance and reliability activities such as preventive maintenance, job plan and datasheet development in Maximo.
• Apply knowledge of Operational Excellence practices such as lean maintenance to drive continuous improvement.
• Responsible for completion of process equipment periodic review, data integrity assessment and security assessment in a timely manner
• Collect, organize, analyze and present results for operational issues or engineering projects of various scale and complexity.

PERSOLKELLY Singapore Pte Ltd • RCB No. 200007268E EA License No. 01C4394 • EA Registration No. R21103542 (Ling Kai Jin)

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