Contract Validation Engineer (Medical Device) - Up to $6,500 #HHL

Recruit Express Pte Ltd.; Singapore; On-site; SGD 66,000 - 79,000; Part time

Job summary

Recruit Express Pte Ltd is seeking a Contract Validation Engineer (Medical Device) to support the setup of new manufacturing lines and lead validation activities. You will perform IQ, TMV and OQ, develop validation protocols and generate technical reports.

The role requires a degree in Engineering/Science with at least two years of relevant experience, plus strong writing and analytical skills. The position is a 12-month contract in Changi, Singapore, with standard Mon–Fri hours and potential

Qualifications

• Min. degree in Engineering, Science or related field.
• Minimum 2 years of relevant engineering/manufacturing experience.
• Experience working with industrial/manufacturing equipment.
• Strong technical writing, analytical and troubleshooting skills.

Responsibilities

• Support start-up and setup of 5 new manufacturing equipment lines.
• Execute equipment validation activities including IQ, TMV, and OQ.
• Develop and execute validation protocols, analyse results and prepare technical reports.
• Optimise manufacturing processes using Lean / Six Sigma methodologies.
• Support equipment, tooling and fixture improvements.
• Investigate and resolve manufacturing and compliance issues including CAPA, non-conformances and audit observations.
• Develop work instructions, training materials and manufacturing documentation.
• Establish project plans, risk assessments and validation deliverables.
• Coordinate technicians, vendors and cross-functional stakeholders.
• Work closely with Engineering, Quality, Supply Chain, Procurement and Supplier Quality teams.

Skills

Technical writing

Analytical thinking

Project coordination

Stakeholder management

Education

Bachelor's degree in Engineering/Science

Tools

MES experience

PLC proficiency

Pneumatic diagram interpretation

Job description

Contract Validation Engineer (Medical Device) - Up to $6,500 #HHL

Recruit Express will never request for your Singpass details in our recruitment process. Please contact us at 6732 6006 or email to [e-mail] if you are unsure if it is a scam.

Changi
Up to $6,500/month
12-Month Contract | Renewable
Mon–Fri, 8am–5pm
Transport pick-up points: Tampines, Punggol, Yishun & Sembawang

Responsibilities

• Support start-up and setup of 5 new manufacturing equipment lines
• Execute equipment validation activities including IQ, Test Method Validation (TMV) and OQ
• Develop and execute validation protocols, analyse results and prepare technical reports
• Optimise manufacturing processes using Lean / Six Sigma methodologies
• Support equipment, tooling and fixture improvements
• Investigate and resolve manufacturing and compliance issues including CAPA, non-conformances and audit observations
• Develop work instructions, training materials and manufacturing documentation
• Establish project plans, risk assessments and validation deliverables
• Coordinate technicians, vendors and cross-functional stakeholders
• Work closely with Engineering, Quality, Supply Chain, Procurement and Supplier Quality teams

Requirements

• Min. degree in Engineering, Science or related field
• Minimum 2 years of relevant engineering / manufacturing experience
• Experience working with industrial / manufacturing equipment
• Strong technical writing, analytical and troubleshooting skills
• Good stakeholder and project coordination skills
• MES experience advantageous
• PLC proficiency, pneumatic diagram interpretation and strong equipment troubleshooting skills advantageous
• Medical device / FDA-regulated environment experience advantageous

Alex Goh Hock Leong
CEI No.: R1763413
Recruit Express Pte Ltd (Healthcare & Life Sciences)
EA Licence No.: 99C4599