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Position: Manager MSAT – Process Engineering
Location: Vizag, Andhra Pradesh
- Coordination with Production, Engineering, Validation, and Quality as per requirements to achieve the business requirements of Technology Transfer/Product Transfer activities.
- Provide technical support for the process and equipment during technology transfer.
- Technical support for Investigations and CAPAs for Process equipment.
- To ensure and adhere to the Pfizer EHS requirements for safety at the work.
- To lead and Coordination with internal teams mechanical, Instrumentation, and Automation as per functional requirements and to build good working relationships with cross-functional and interdepartmental teams to lead the entire project team of all disciplines.
- Engineering support for Equipment Qualification activities DQ, FAT, recipient of equipment, SAT, Commissioning, IQ, OQ, PQ-qualification of equipment as per the Qualification protocols and Technical Support to the user for various deliverables.
- Responsible for preparation of various regulatory inspections, audits, and need-based active participation during audits, Standardization of Engineering Systems through Planning & Monitoring, Benchmarking, Facility Technical Audits, and Inventory & Contract Management.
- Provides process engineering support for site-to-site parenteral product transfers by interfacing with cross-functional departments across sites.
- Conducts equipment and process-related technical investigations and makes recommendations on corrective Prepares, reviews, and provides input on user requirements specification (SRS) documents and P&IDs
- Will lead activities to implement novel technologies for process improvements to increase yield and reduce process variability
- Leverage PAT tools for rationale-based product transfers between sites and across scales
- Be able to apply QbD and DOE principles during the design of investigation studies
- Basic understanding of mathematical and statistical modeling
- Provides necessary technical support to manufacturing, validation and engineering teams as required
- Designs experimental plan and drafts technical reports summarizing laboratory results as part of investigations
- Ensure the compliance with cGMP/cGLP, organizational procedures, and practices
- Involve in manufacturing, Validations/engineering related CAPAs and monitor the effectiveness of CAPAs
- Seek training from technology vendors and train the end-users
- Experience in Process Engineering aspects related to sterile drug product/injectables manufacturing
- Holistic understanding of TS equipment train i.e Formulation process equipment, automation hands-on experience, stopper processing Filling, Terminal sterilization, and visual inspection.
- Hands-on experience in parenteral process development and manufacturing.
- Good knowledge of Sterile pharma equipment and its engineering aspects.
- Problem-solving skills
- Process analytical skills
- Hands-on experience leading the investigations independently.
- Yellow belt certification is a must.
- Candidates who have submitted M2 or green belt project will be preferred
Standards, Processes & Policies
- cGMP and GDP
Behavioral/Any Other Skills
- Good Communication & Presentation Skills
- Effective negotiation, influential and Interpersonal Skills
- Leadership Skills
Qualification: B.Tech/B.E, M.Tech
Experience: 8-14 Years
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