Senior Production Engineer

Senior Production Engineer provides strong technical process oversight by leading all manufacturing process continuous improvement and qualification activities within our Thailand operations.

1 - Analyzing production process flow to identify and optimize bottlenecks by implementing solutions for yield and productivity continuous improvement

2 - Perform equipment/process qualification and periodic evaluation/re-validation related to manufacturing processes, cleaning, utilities and facilities

Mission 1:Manufacturing Process Subject Matter Expert

-Study and understand existing production processes

-Monitor and recommend improvements for the existing production process to assess their impact on product quality

-Utilizes process simulation software to monitor and optimize the most appropriate production strategies

-Conducts risk assessments to ensure compliance with safety and quality standards (i.e. FMEA, HACCP, others)

-Technical writing and communication to relevant site stakeholders through comprehensive documentation that meets organizational standards to ensure compliance with cGMP / ISO9001

-Present process qualification/validation reports during audits and inspections

Mission 2: Continuous Improvement & Qualification

-Continually ensure equipment, utilities and facilities and assess their impact on product quality

-Assembles reports to document process equipment lifecycle qualification status

-Suggest continuous improvement technological upgrades maintaining expected level of regulatory requirements

-Consult with production staff and management to provide troubleshooting instructions; enabling them to implement and sustain improvements

-Conducts relevant gap assessments and risk assessments (i.e. ICH Q9) for new equipment or processes

-Lead, organize and train staff in qualification and validation activities

-Present equipment qualification/validation reports during audits and inspections

Professional experience

oMinimum of 5 years of industry experience in process engineering in GMP or ISO9001 manufacturing environment(s)

oExperienced knowledge of production machinery, processes, and standards

oExperienced knowledge of chemical processes

oKnowledge of equipment qualification (design and installation), process validation/ technology transfer & process monitoring (data trending, statistical analysis)

Skills

oProactive mindset

oCritical thinking and problem-solving skills (project management and investigation support)

oStrong communication and presentation skills

oDocumentation and organization skills

oTroubleshooting skills and attention to detail

Note: Candidacy is only open to Thai nationals who are authorized to work in Thailand. No work permit or visa will be supported or available.