Engineer II, Process

Vantive Manufacturing Pte. Ltd.; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

Vantive Manufacturing Pte. Ltd. in Singapore is seeking an Engineering Projects Manager to lead product and process change initiatives across manufacturing lines.

You will liaise with stakeholders on requirements, timelines and validation, and drive change control activities to ensure performance and compliance. The role covers optimizing processes with Lean tools, supporting maintenance engineering, and coordinating with regulatory affairs to meet GMP standards for medical/pharma manufacturing.

Qualifications

• Degree in Mechanical/Mechatronic Engineering or equivalent.
• 3+ years in engineering projects management and coordination.
• Experience in medical/pharmaceutical manufacturing context preferred.
• Knowledge of IQ/OQ/PQ would be an added advantage.

Responsibilities

• Manage projects / Product or Process Change and Enhancement.
• Improve capability of manufacturing processes with higher predictability and lower production costs.
• Support manufacturing and maintenance engineering.
• Analyze machine/process issues related to customer complaints and implement effective corrective and preventive action.
• Label Change: feasibility studies, deadlines, implementation, and regulatory alignment.
• Ensure compliance with Environment, Health & Safety (EHS) procedures.

Skills

Project management

Change management

Stakeholder liaison

Lean manufacturing

Maintenance & TPM

GMP familiarity

IQ/OQ/PQ knowledge

Education

Degree in Mechanical/Mechatronic Engineering or equivalent

Job description

Essential Duties and Responsibilities

This section contains a list of primary responsibilities of work. The incumbent will perform other duties as assigned

• 1. Manage projects / Product or Process Change and Enhancement
  • a. Liaise with stake holders on requirements, technical specifications, deadlines, work schedules, feasibility, implementation and validation.
  • b. Assist in product design change project that affects product performance.
  • c. Lead change control process, specification change and validation activities.
• 2. To improve the capability of the manufacturing processes with higher predictability and lower production costs.
  • a. Identify productivity improvement opportunities, recommend changes to machine parts designs, conduct feasibility studies and liaise with the stake holder on the implementation.
  • b. Effective use of Lean tools to improve overall machine performance (eg, OEE).
  • c. Implement Energy / Water conservation projects.
  • d. Ensure process is stable and capable of meeting all product requirements while maintaining a safe working environment. Verify that machine-produced parts are of acceptable quality, safe to operate and environmentally friendly. Conduct validation studies and process investigations.
• 3. Support manufacturing and maintenance engineering.
• 4. Analyze machine and/ or process issue related to customer complaint and implement effective corrective and preventive action.
  • a. May include leading a group of technicians to support manufacturing activities. Study parts life and establish PM schedule for TPM activities.
• 5. Label Change
  • a. Evaluate project requests from countries or regions with Plant operations, quality and planning to conduct feasibility studies to determine technical specifications, validation, deadlines and implementation.
  • b. Work with supply chain and marketing on deadlines to implement changes and product transition to new changes.
  • c. Draft label copy artworks and drawings in accordance with requirements and technical specifications.
  • d. Liaise with procurement / vendors on requirements and verifications of product samples.
  • e. Interact with Regulatory Affairs & Marketing on latest developments in regional requirements in respective countries and implementing those changes to meet requirements.
• 6. Responsible for compliance with Environment, Health & Safety (EHS) procedure and requirement.

Qualification / Education

• Degree in Mechanical/Mechantronic Engineering or equivalen

Skill Set / Experience

• Degree with Min 3 years experience / Fresh Degree are welcomed to apply
• 2-3 years experience in engineering projects management and coordination
• Good engineering background in industrial automation, electrical and controls engineering
• Experience in new manufacturing machinery commissioning, debugging and validation
• Familiarize with basic GMP and other relevant requirements for medical/ pharmaceutical products manufacturing
• Knowledge of Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) would be an added advantage.