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Position: Manager MSAT – Process Engineering

Location: Vizag, Andhra Pradesh

Job Description:

Responsibilities

  • 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

Technical Skills

  • 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

Salary: Negotiable

Contact Details:

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