1 year contract Technical Specialist ( Pharma MNC) #HJH

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a Technical Specialist to support manufacturing operations in a leading biologics environment. The role emphasizes factory readiness, deviation investigations, and collaboration with cross-functional teams to ensure compliant product release and process campaigns.

The ideal candidate holds a degree with manufacturing/process engineering or QA operations experience, strong hands-on deviation investigation skills, and a track record in change control and

Qualifications

• Degree and experience in manufacturing, process engineering or QA operations.
• Hands-on experience in deviation investigation.
• Experience supporting manufacturing readiness and change control.

Responsibilities

• Support technology transfers and manufacturing process campaigns.
• Develop and revise Master Batch Records (MBRs).
• Manage Change Requests and controlled documentation.
• Support operational risk assessments and pre-campaign training.
• Ensure manufacturing readiness before process campaigns.
• Support assessment and management of manufacturing deviations.
• Manage CAPAs, tasks and rejected materials.
• Participate in deviation-related audits and investigations.
• Support manufacturing teams during process campaigns.
• Work closely with cross-functional teams to resolve operational issues.
• Lead deviation investigations and trend investigations.
• Perform root cause analysis and identify appropriate CAPAs.
• Conduct product impact assessments.
• Support timely lot disposition and product release activities.
• Prepare clear and accurate technical documentation.

Skills

Deviation investigation

Process engineering

QA operations

Manufacturing

Education

Bachelor's degree in manufacturing/engineering or related field

Job description

Technical Specialist - Manufacturing Operations

Looking for Technical Specialists to support manufacturing operations within a leading biologics environment.

This is an excellent opportunity for candidates with a Degree and experience in manufacturing, process engineering or QA operations, particularly those with strong hands-on experience in deviation investigation.

What You'll Be Doing

Manufacturing Readiness

• Support technology transfers and manufacturing process campaigns
• Develop and revise Master Batch Records (MBRs)
• Manage Change Requests and controlled documentation
• Support operational risk assessments and pre-campaign training
• Ensure manufacturing readiness before process campaigns

Manufacturing Operations

• Support assessment and management of manufacturing deviations
• Manage CAPAs, tasks and rejected materials
• Participate in deviation-related audits and investigations
• Support manufacturing teams during process campaigns
• Work closely with cross-functional teams to resolve operational issues

Deviation Investigation & Product Release

• Lead deviation investigations and trend investigations
• Perform root cause analysis and identify appropriate CAPAs
• Conduct product impact assessments
• Support timely lot disposition and product release activities
• Prepare clear and accurate technical documentation