Process Engineering Lead
2 weeks ago
Process Engineering Lead (Including operation and maintenance of Clean Utilities)Lead a team of engineers and technicians in managing maintenance and calibration of aseptic Drug Product and Drug Substance facilities. Lead the team in maintaining Drug Product aseptic clean room, vials, pre-filled syringes lines, vials lines with lyophilizer, automatic inspection machines. Maintain lyophilizers and its associated systems with high operation efficiencies (High OEE with minimum downtime). Lead the team in maintaining Drug Substance aseptic clean room, Pre-filled-syringes filling lines, hybrid solution preparation systems in optimum operating efficiencies (High OEE with minimum downtime). Support Global Engineering Team and Validation/Operation team in project design review, selection of equipment, testing/commissioning and IOPQ support. Author, review, and approve documents, URS, FRS and protocols related to process engineering and both maintenance and calibration strategies for both DP and DS facilities. Collaborate with Central Utilities and planning/scheduling teams to organize efficient implementation of DP/DS maintenance and calibration. Lead Failure Mode Analysis, deviation reporting and CAPA resolution and CAPA effectiveness monitoring. Be Package Owner of Operation and Maintenance of Cleaning Utilities (CU and/or Equipment—PW, WFI and distribution loop), including URS preparation, review and approval, bidding, packaging delivery, site installation, commissioning and qualification support. Support project management teams or EPCM on project execution. Lead role in Process Engineering operation readiness and start-up preparation including SOPs, PM system, Calibration system, routine inspection, technical authority, special equipment management, energy management, engineering maintenance budget, engineering compliance, etc. Introduce predictive operation and maintenance strategy to raise reliability engineering to world-class standards. Drive and lead the Process Engineering team in continuous improvement programs, machine learning or computer-assisted maintenance (predictive or condition monitoring via AI or machine learning). Support strategic planning for facilities expansion. Be responsible for working with government agencies in engineering related matters. As Process Lead, integrate the department with other departments to promote teamwork and HR initiatives. Host client and authority inspections and audits on engineering aspects. Implement knowledge management to upgrade skills and capabilities of the Process Engineering team. Be responsible for EHS and Quality compliance for the department. Other ad hoc projects or tasks as required. Requirements Bachelor or above degree in Engineering. (years / professional experience / industry experience / management experience)> 15 years in Engineering roles preferably 5 years at Senior management level. > 10 years in Pharmaceutical aseptic Drug product filling and Drug substance manufacturing. Prior experience in Greenfield project preferred. Professional knowledge & Capability requirements & Accountability Good knowledge of GMP and associated Biologics regulatory guidelines (FDA/ICH/PIC/S and WHO guidelines). Lean concept and knowledge preferred. Fluent English (written and spoken). Fluent Chinese (spoken) preferred. Engineering, system, process, compliance, people management, leadership and continuous improvement. Seniority level Director Employment type Full-time Job function Other Industries Pharmaceutical Manufacturing #J-18808-Ljbffr
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Process Engineer
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Lead Cqv Engineer- Process/fue-pharma
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Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full timePES is an international services company providing Project Management, Construction Management, Commissioning & Qualification, and Automation services to our clients in the pharmaceutical, nutritional, and related sectors. With offices across Europe, Asia, and the US, our core focus is on consistently delivering high-quality outcomes for our multinational...
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Process/ms&t Engineer-pharma/biopharma
5 days ago
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Senior Executive
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Singapore Process Engineering Specialists Full timeA leading engineering services company in Singapore is seeking a Senior Process Engineer to work on downstream processes in the bio-pharma sector. Candidates must have at least 5 years of relevant experience, including knowledge of chromatography and sterile filtration. The position involves process mapping, troubleshooting, and working during the...
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Process Engineer
2 weeks ago
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Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full timePES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational...
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Process Safety Manager-gmp/pharma
1 week ago
Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full timePES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational...
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Lead Process Engineer
2 weeks ago
Singapore Spencer Ogden Full timePosition: Lead Process Engineer Reports to: Head of Engineering Location: Asia-Pacific Overview We are seeking a Lead Process Engineer to guide process design and technical execution for a major industrial-scale project in the energy and resources sector. This leadership position focuses on scaling emerging process technologies from concept through to...
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2 weeks ago
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