Senior Process Engineer (Tuas, Biotech firm)

This role requires highly cross-functional interactions with key site functions to ensure success in production and release performance. The individual must be able to effectively communicate and collaborate closely with team members and various SMEs to ensure equipment is operational to sustain daily operations, resolve operational challenges, and implement effective measures to address these challenges without compromising safety and compliance. Location: Tuas Salary up to $100001 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 with 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. Promptly update or escalate 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 the 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 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. 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-functional 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 and effectively communicate to customers on subsequent plans and actions. Collaborate closely with cross-functional SMEs to implement effective corrective and preventive actions and improvements. Ensure operation continuity through asset lifecycle management planning, assessing and identifying impacts to safety, compliance, operational schedule, and cost. Perform assessments for equipment during new product introduction, change controls, and other qualification activities to ensure equipment is in its validated state. Accountable for deviation/change control associated with 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 scales and complexity. #J-18808-Ljbffr