Senior MSAT Engineer
at ANTAES ASIA PTE LTD
Singapore, Southeast, Singapore -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 09 Nov, 2024 | USD 6000 Monthly | 09 Aug, 2024 | 4 year(s) or above | Policy Writing,Biotechnology,Mes,Sap,Life Science,Pharmaceutical Industry,Chemical Engineering | No | No |
Required Visa Status:
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US Citizen | Student Visa |
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OPT | H4 Spouse of H1B |
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Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
VALIDATIONS:
- Coordinate/execute the development of new validation processes or troubleshoot existing ones.
- Schedule and execute validations/qualifications as per SOPs and regulatory guidelines.
- Coordinate testing with functional groups, evaluate test results, and document various reports and documentation related to validation.
- Execute equipment and process validation studies, participate in audits, and contribute to validation program developments/improvements to remain compliant with cGMPs and industry standards.
- Work with other departments to troubleshoot equipment, process, and validation issues, conducting deviation investigations and implementing corrective actions.
- Support QA validation SMEs during audits.
SKILLS, KNOWLEDGE & EXPERIENCE:
- Hold a BS or higher degree in relevant fields like Chemical Engineering, Mechanical Engineering, Biotechnology, or related Life Science.
- Possess demonstrated skill and knowledge in analytical methods, equipment, processes, validation strategies, and policy writing.
- Have 4-5 years of experience in Engineering, pharmaceutical industry, or equivalent education.
- Experience with Ultrafiltration/diafiltration systems is required as well as CIP/SIP/Cleaning
- Knowledge of downstream purification processes or upstream processes will be beneficial.
- Familiarity with global regulations and validation/qualification requirements.
- Possess equipment and process troubleshooting skills.
- Experience in product/process development and project management is advantageous.
- Deep knowledge in SAP & ME
Responsibilities:
- Address technical deviations and Corrective and Preventive Actions (CAPAs).
- Investigate and troubleshoot process and equipment issues.
- Act as a Subject Matter Expert (SME) for technical equipment and provide relevant training.
- Manage quality and business-continuity risks by conducting necessary risk assessments for mitigation plans.
- Conduct Gap analysis and follow-up on Quality Management System (QMS), Quality alerts, and VSOPs.
- Prepare documentation to support operational activities.
- Provide technical leadership and conduct root cause analysis sessions for quality deviations, equipment/system issues, and incidents, implementing corrective and preventive actions.
- Participate in technical teams for discrepancy resolution, investigation, equipment/process validation activities, and training on new process technologies.
- Lead/Support change controls and their implementation for process equipment or associated manufacturing processes, providing training to the team on these changes.
- Collaborate with the production team to meet production schedules, ensure commercial supply, maintain quality standards, and strive for zero defects.
- Design processes to optimize process flow efficiency, reduce variability, defects, improve process capability, maintain quality standards, and enhance employee safety.
- Implement changes/updates to manufacturing processes and work with manufacturing, engineering, MSAT teams, and QA validation to execute those changes.
- Review/provide feedback and technical/scientific support on project deliverables such as remediation initiatives, value creation projects, technological advancements, and strategic site priority projects.
- Establish experimental protocols, conduct experiments, analyze results, and document information to support investigations, CAPA, risk, change control, or continuous improvement efforts.
- Collaborate closely with MSAT Product Stewardship team to identify critical process parameters for equipment and process validation.
REQUIREMENT SUMMARY
Min:4.0Max:5.0 year(s)
Mechanical or Industrial Engineering
Production / Maintenance / Quality
Mechanical Engineering
BSc
Mechanical Engineering, Chemical, Engineering
Proficient
1
Singapore, Singapore