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MSAT Engineer
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MSAT Engineer
Asia - Singapore
Industrial Engineering and Life-Science
Permanent
6/24/2024
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About the role
Job Description:
Technical Leadership & Quality Management:
- Manage technical deviations, CAPAs, and equipment/process troubleshooting.
- Conduct training and serve as SME for technical equipment.
- Perform risk assessments and gap analyses to mitigate quality and business risks.
- Lead root cause analysis sessions for quality deviations and equipment issues, implementing corrective actions.
Process Optimization & Continuous Improvement:
- Identify and implement process improvements to enhance yield, capacity, and cost-efficiency.
- Lead initiatives to reduce process variability and improve robustness, while maintaining compliance.
- Serve as the technical representative for process-related equipment issues.
- Manage start-up efforts for new equipment, software, or processes.
Project Management:
- Oversee projects focused on process optimization, troubleshooting, and new equipment introduction.
- Prepare necessary documentation, including protocols, reports, and risk assessments.
- Participate in design, development, validation strategy, and routine GMP activities.
- Represent MSAT during technical transfers and GMP activities.
Validation Coordination:
- Develop and troubleshoot validation processes, ensuring compliance with SOPs and regulatory guidelines.
- Execute validation studies, including protocol preparation, execution, data analysis, and reporting.
- Participate in audits and improvements to validation programs.
Audit Preparation & Management:
- Support and lead Management Monitoring (MM) audits.
- Participate in IBM audits, corporate, and regulatory inspections, providing expertise as SME.
Environment, Health, Safety, and Wellness:
- Promote and participate in site safety and wellness initiatives.
- Follow safety training and regulations, using PPEs correctly.
- Report unsafe situations and participate in safety inspections.
- The role involves working closely with MSAT Product Stewardship, Process Science & Manufacturing Technology teams, QA validation, and cross-functional teams to ensure smooth operations and continuous improvements in manufacturing processes.
- Maintain comprehensive documentation to support operational activities, investigations, CAPAs, risk assessments, and continuous improvement initiatives. Ensure all actions comply with current Good Manufacturing Practices (cGMPs) and industry standards.
- Contribute to Life Science projects for Antaes Asia clients
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Your profile
Job Requirements:
- Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science
- 4-5 years' experience in Engineering, pharmaceutical industry
- Demonstrated skill and knowledge with analytical methods, equipment, process, software, cleaning, and facility/utility validation strategies and policy, protocol and report writing and execution.
- Experience in Ultrafiltration/diafiltration systems is preferred.
- Knowledge of other downstream purification process (e.g. Chromatography) or upstream process (e.g. Fermentation) will add value
- Equipment and process troubleshooting skills
- Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired.
- Experience with product/process development and project management is a plus.
- Lean Sigma/Green Belt certification is a plus.
- Continuous improvement mindset
- Adherence to safety protocols and global regulatory compliance
- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
- Organization and transformation consulting
- Industrial Engineering
- Information Systems Management
By joining our teams you will discover :
- A dynamic team in a start-up spirit
- Human support and career development monitoring
- Challenges to help develop your network
- Events: team building, meet-up, workshop, Winter Event ...
-
An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)
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- Develop and industrialize ranges and bills of materials for new products.
- Manage activity planning and risk management.
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MSAT Engineer
Asia - Singapore
Industrial Engineering and Life-Science
Permanent
About the role
Job Description:
Technical Leadership & Quality Management:
- Manage technical deviations, CAPAs, and equipment/process troubleshooting.
- Conduct training and serve as SME for technical equipment.
- Perform risk assessments and gap analyses to mitigate quality and business risks.
- Lead root cause analysis sessions for quality deviations and equipment issues, implementing corrective actions.
Process Optimization & Continuous Improvement:
- Identify and implement process improvements to enhance yield, capacity, and cost-efficiency.
- Lead initiatives to reduce process variability and improve robustness, while maintaining compliance.
- Serve as the technical representative for process-related equipment issues.
- Manage start-up efforts for new equipment, software, or processes.
Project Management:
- Oversee projects focused on process optimization, troubleshooting, and new equipment introduction.
- Prepare necessary documentation, including protocols, reports, and risk assessments.
- Participate in design, development, validation strategy, and routine GMP activities.
- Represent MSAT during technical transfers and GMP activities.
Validation Coordination:
- Develop and troubleshoot validation processes, ensuring compliance with SOPs and regulatory guidelines.
- Execute validation studies, including protocol preparation, execution, data analysis, and reporting.
- Participate in audits and improvements to validation programs.
Audit Preparation & Management:
- Support and lead Management Monitoring (MM) audits.
- Participate in IBM audits, corporate, and regulatory inspections, providing expertise as SME.
Environment, Health, Safety, and Wellness:
- Promote and participate in site safety and wellness initiatives.
- Follow safety training and regulations, using PPEs correctly.
- Report unsafe situations and participate in safety inspections.
- The role involves working closely with MSAT Product Stewardship, Process Science & Manufacturing Technology teams, QA validation, and cross-functional teams to ensure smooth operations and continuous improvements in manufacturing processes.
- Maintain comprehensive documentation to support operational activities, investigations, CAPAs, risk assessments, and continuous improvement initiatives. Ensure all actions comply with current Good Manufacturing Practices (cGMPs) and industry standards.
- Contribute to Life Science projects for Antaes Asia clients
- Contribute to the promotion of Antaes services on top of assistance provided to clients
Your profile
Job Requirements:
- Bachelor degree in Science, Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science
- 4-5 years' experience in Engineering, pharmaceutical industry
- Demonstrated skill and knowledge with analytical methods, equipment, process, software, cleaning, and facility/utility validation strategies and policy, protocol and report writing and execution.
- Experience in Ultrafiltration/diafiltration systems is preferred.
- Knowledge of other downstream purification process (e.g. Chromatography) or upstream process (e.g. Fermentation) will add value
- Equipment and process troubleshooting skills
- Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired.
- Experience with product/process development and project management is a plus.
- Lean Sigma/Green Belt certification is a plus.
- Continuous improvement mindset
- Adherence to safety protocols and global regulatory compliance
- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
Our positions are open to people who have been recognized as disabled workers. T&S Group promotes diversity and equality in the workplace. All qualified M/F candidates are considered for employment on an equal basis.
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
- Organization and transformation consulting
- Industrial Engineering
- Information Systems Management
By joining our teams you will discover :
- A dynamic team in a start-up spirit
- Human support and career development monitoring
- Challenges to help develop your network
- Events: team building, meet-up, workshop, Winter Event ...
-
An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)
