Responsibilities:
1. Address technical deviations and Corrective and Preventive Actions (CAPAs).
2. Investigate and troubleshoot process and equipment issues.
3. Act as a Subject Matter Expert (SME) for technical equipment and provide relevant training.
4. Manage quality and business-continuity risks by conducting necessary risk assessments for mitigation plans.
5. Conduct Gap analysis and follow-up on Quality Management System (QMS), Quality alerts, and VSOPs.
6. Prepare documentation to support operational activities.
7. Provide technical leadership and conduct root cause analysis sessions for quality deviations, equipment/system issues, and incidents, implementing corrective and preventive actions.
8. Participate in technical teams for discrepancy resolution, investigation, equipment/process validation activities, and training on new process technologies.
9. Lead/Support change controls and their implementation for process equipment or associated manufacturing processes, providing training to the team on these changes.
10. Collaborate with the production team to meet production schedules, ensure commercial supply, maintain quality standards, and strive for zero defects.
11. Design processes to optimize process flow efficiency, reduce variability, defects, improve process capability, maintain quality standards, and enhance employee safety.
12. Implement changes/updates to manufacturing processes and work with manufacturing, engineering, MSAT teams, and QA validation to execute those changes.
13. Review/provide feedback and technical/scientific support on project deliverables such as remediation initiatives, value creation projects, technological advancements, and strategic site priority projects.
14. Establish experimental protocols, conduct experiments, analyze results, and document information to support investigations, CAPA, risk, change control, or continuous improvement efforts.
15. Collaborate closely with MSAT Product Stewardship team to identify critical process parameters for equipment and process validation.
Validations:
1. Coordinate/execute the development of new validation processes or troubleshoot existing ones.
2. Schedule and execute validations/qualifications as per SOPs and regulatory guidelines.
3. Coordinate testing with functional groups, evaluate test results, and document various reports and documentation related to validation.
4. Execute equipment and process validation studies, participate in audits, and contribute to validation program developments/improvements to remain compliant with cGMPs and industry standards.
5. Work with other departments to troubleshoot equipment, process, and validation issues, conducting deviation investigations and implementing corrective actions.
6. Support QA validation SMEs during audits.
Skills, Knowledge & Experience:
1. Hold a BS or higher degree in relevant fields like Chemical Engineering, Mechanical Engineering, Biotechnology, or related Life Science.
2. Possess demonstrated skill and knowledge in analytical methods, equipment, processes, validation strategies, and policy writing.
3. Have 4-5 years of experience in Engineering, pharmaceutical industry, or equivalent education.
4. Experience with Ultrafiltration/diafiltration systems is required as well as CIP/SIP/Cleaning
5. Knowledge of downstream purification processes or upstream processes will be beneficial.
6. Familiarity with global regulations and validation/qualification requirements.
7. Possess equipment and process troubleshooting skills.
9. Experience in product/process development and project management is advantageous.
10. Deep knowledge in SAP & MES
