Senior Production Engineer
7 days ago
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
o Minimum of 5 years of industry experience in process engineering in GMP or ISO9001 manufacturing environment(s)
o Experienced knowledge of production machinery, processes, and standards
o Experienced knowledge of chemical processes
o
Knowledge of equipment qualification (design and installation), process validation/ technology transfer & process monitoring (data trending, statistical analysis)
Skills
o Proactive mindset
o Critical thinking and problem-solving skills (project management and investigation support)
o Strong communication and presentation skills
o Documentation and organization skills
o
Troubleshooting 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.
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