Process Engineering Lead

1 week ago

Singapore WuXi Biologics Full time

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

  • Senior Executive

    7 days ago

    Singapore Sea-lead Full time

    Senior Executive - Business Process Management Department: Business Process Management Experience required: 2 - 4 years Job title: Business Process team Grade: (Specify Grade)Department: Business Process Management Direct reports: N/A Reporting to: (Specify Supervisor)Dotted line reporting: N/A Job purpose: The Business Process team supports and coordinates...

  • Lead Process Engineer

    2 weeks ago

    Singapore CONNECTe International Pte Ltd Full time

    Job Description: This role requires good organizational/coordination skills and management of a small team of process engineers. Direct contact with the client and vendors will be necessary. The principle role of the Lead Process Engineer is to: - Assist to plan, define, award and manage various Engineering Contractors technical deliverables for both basic...

  • Lead Process Engineer

    1 day ago

    Singapore Peak Ocean Pte Ltd Full time

    **Job Summary**: - This role requires good organizational/coordination skills and management of a small team of process engineers. Direct contact with the client and vendors will be necessary. The principle role of the Lead Process Engineer is to:_ - Assist to plan, define, award and manage various Engineering Contractor’s technical deliverables for both...

  • Lead Process Engineer

    7 days ago

    Singapore Connect Energy Full time

    Connect Energy partners with an O&G company to look for a LEAD PROCESS ENGINEER to work on their upcoming project. Responsibilities Focal for Process discipline in project management team for CAPEX projects and supervise FEED consultants, EPC contractors and Equipment vendors Prepare and issue Process basis of design, project specifications and scope of work...

  • Lead Process Engineer

    2 weeks ago

    Singapore Connect Energy Full time

    Connect Energy partners with an O&G company to look for a LEAD PROCESS ENGINEER to work on their upcoming project. Responsibilities Focal for Process discipline in project management team for CAPEX projects and supervise FEED consultants, EPC contractors and Equipment vendors Prepare and issue Process basis of design, project specifications and scope of...

  • Project Engineer

    7 days ago

    Singapore MATIC ENGINEERING & PROCESS PTE. LTD. Full time

    Job Responsibilities Conduct and review engineering calculations for equipment sizing, material selection, and system design. Lead the development of detailed design documents, including process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and system layouts. Oversee and coordinate with multidisciplinary teams to ensure seamless...

  • Project Engineer

    3 days ago

    Singapore MATIC ENGINEERING & PROCESS PTE. LTD. Full time

    Job Responsibilities Conduct and review engineering calculations for equipment sizing, material selection, and system design. Lead the development of detailed design documents, including process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and system layouts. Oversee and coordinate with multidisciplinary teams to ensure seamless...

  • Project Engineer

    3 days ago

    Singapore Matic Engineering & Process Pte Ltd Full time

    Responsibilities Conduct and review engineering calculations for equipment sizing, material selection, and system design. Lead the development of detailed design documents, including process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and system layouts. Oversee and coordinate with multidisciplinary teams to ensure seamless integration...

  • Lead Engineer

    1 day ago

    Singapore KBR Full time

    Job Responsibilities: - Lead process engineering and design, process configuration and optimization studies - Perform Process simulations, prepare Process/Utility Flow Diagrams, Heat and Material Balance, Utility Balance - Prepare Piping and Instrumentation diagrams - Prepare Process equipment datasheets, instrument datasheets - Perform relief and blowdown...

  • Lead Process Engineer

    1 day ago

    Singapore Peak Ocean Pte Ltd Full time

    **Overall Job Purpose**: To independently define concepts and critical deliverables, lead, plan, manage, control, engineering deliverables required for the assigned project effectively and efficiently according to specified technical requirements, timelines and budget, manage project resources and independently deal with and resolve all issues of the...