Contract Validation Engineer (Medical Device)

About the role

A 12-month renewable contract for a Contract Validation Engineer in a medical device setting, based in Singapore. The role supports the start-up and setup of five new manufacturing equipment lines, with transport pick-up points in Tampines, Punggol, Yishun and Sembawang. Pay is listed as 5,000 to 7,000 SGD per month.

Key responsibilities

• Support the start-up and setup of five new manufacturing equipment lines
• Execute equipment validation activities including IQ, Test Method Validation (TMV) and OQ
• Develop and run 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, working with Engineering, Quality, Supply Chain, Procurement and Supplier Quality teams

Required profile

• Minimum degree in Engineering, Science or a related field
• Minimum 2 years of relevant engineering or manufacturing experience
• Experience working with industrial or manufacturing equipment
• Strong technical writing, analytical and troubleshooting skills
• Good stakeholder and project coordination skills

Required skills

• MES experience is advantageous
• PLC proficiency, pneumatic diagram interpretation and strong equipment troubleshooting skills are advantageous
• Medical device or FDA-regulated environment experience is advantageous

Candidates apply through the recruiter by sending their resume by email or via Telegram.