- Analyzing production process flow to identify and optimize bottlenecks by implementing solutions for yield and productivity continuous improvement
- Perform equipment/process qualification and periodic evaluation/re-validation related to manufacturing processes, cleaning, utilities and facilities
Job Description
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
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
Qualifications
- Bachelor's or master's degree in chemical engineering (preferred) or Industrial Engineering (with knowledge of chemical processes)
- Minimum of 7 years of industry experience in process engineering in GMP or ISO9001 manufacturing environment(s)
- Experienced knowledge of production machinery, processes, and standards
- Experienced knowledge of chemical processes
- Knowledge of equipment qualification (design and installation), process validation/ technology transfer & process monitoring (data trending, statistical analysis)
- Proactive mindset
- Critical thinking and problem-solving skills (project management and investigation support)
- Strong communication and presentation skills
- Documentation and organization skills
- Troubleshooting skills and attention to detail
- Proficiency in use of MS Office/Project, MiniTab ,AutoCAD and DCS
- Good command of English (spoken/conversational and written)
