Senior/MSAT Manufacturing Support Engineer
2 months ago
We are seeking a highly skilled and experienced Manufacturing Science and Technology Support Specialist to join our team at 825 Glaxo Wellcome Manufacturing Pte Ltd. As a key member of our MSAT department, you will play a critical role in driving commercial manufacturing processes improvements and providing technical expertise in various process disciplines.
Key Responsibilities- Process Optimization and Validation: Develop and implement process improvements to optimize efficient process flow, reduce process or product variability, reduce defects, improve process capability, and uphold quality standards.
- Technical Support: Provide technical expertise and support to Value Streams to deliver their operational objectives optimally and in compliance with cGMP requirements.
- Deviation Investigations and CAPA Management: Manage technical deviations and CAPAs, and lead root cause analysis sessions to identify and implement corrective and preventive actions.
- Equipment and Process Troubleshooting: Troubleshoot process and equipment issues, and conduct relevant training as a Subject Matter Expert.
- Quality and Business-Continuity Risks: Ensure necessary risk assessments are performed to justify or identify necessary mitigation plans.
- Documentation and Reporting: Prepare documents as required to support the activities of the operations department, and participate in the development of validation programs.
- Project Management: Manage projects related to process optimization, routine production issues troubleshooting, new equipment introduction and qualification.
- Audit Preparation and Management: Support and lead Management Monitoring (MM) audits, and participate in Independent Business Monitoring (IBM) audits.
- Validations: Coordinate and execute the development of new validation processes, and schedule and execute validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
- Education: Bachelor's degree in Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science.
- Experience: At least 4-5 years' experience in Engineering, pharmaceutical industry, or equivalent education.
- Skills: Demonstrated skill and knowledge with analytical methods, equipment, process, software, cleaning, and facility/utility validation strategies and policy, protocol and report writing and execution.
- Knowledge: Familiarity with global regulations validation/qualification requirements, and knowledge of other downstream purification process or upstream process.
- Equipment and Process Troubleshooting: Experience with equipment and process troubleshooting skills.
- Communication and Teamwork: Highly effective communication, facilitation, negotiation, and teamwork skills.
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