Senior Operations Process Engineer

5 days ago

Mumbai, Maharashtra, India beBeeProcess Full time ₹ 24,00,000 - ₹ 30,00,000
Process Engineer

As a Process Engineer - Senior Manager, you will lead the engineering and operations team to deliver projects that meet our business objectives. You will be responsible for ensuring that all processes are designed and implemented to meet quality and safety standards.

Key Responsibilities:
  • Process Expertise: Develop and implement process improvements to increase efficiency and reduce costs. This includes expertise in operation of process equipment such as aseptic and lyophilisation areas, filtration, filling, Lyophilizer loading and unloading, lyophilisation process, capping, leak test and X ray inspection.
  • Equipment Handling: Ensure that all process equipment is properly maintained and calibrated to ensure optimal performance. This includes handling equipment like vial washing, tunnel sterilizer, filling machine, capping machine, Lyophilizer loading and unloading system, Lyophilizer, filtration skid, and isolators, VHP passbox.
  • Qualification Protocol: Prepare and execute qualification protocols for new equipment to ensure compliance with regulatory requirements. This includes indenting to procurement of new equipment in aseptic areas and lyophilizer areas, preparation of user requirement specification, design qualification, installation qualification, operational qualification and performance qualification.
  • Standard Operating Procedures: Develop and implement standard operating procedures for process and equipment to ensure consistency and quality. This includes preparing new standard operating procedure for process and equipment, experience in preparation of batch manufacturing records.
  • QMS Documents: Manage QMS documents such as change control, CAPA, risk assessment, deviation to ensure compliance with regulatory requirements.
  • Communication: Communicate effectively with vendors and procurement teams on procurement to design parts of new equipment.
  • Compliance: Ensure compliance to cGMP and documentation for various production activities.
  • Project Management: Plan and execute qualification activity in accordance with the plan and allocation of man power.

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