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
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
