Senior Executive - Project And Engineering Plant Maintenance

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks a skilled maintenance engineer for a sterile manufacturing plant. The role involves assisting installation and commissioning of plant machinery, qualification documentation, and executing site installation activities.

You will manage preventive and breakdown maintenance, maintain critical spares, and ensure cGMP/GEP compliance across QMS processes. The candidate should have 3–7 years of experience in engineering plant maintenance in sterile

Qualifications

• Education: Diploma/ BE.
• Total Experience - 3 - 7 years of experience in engineering plant maintenance role for sterile manufacturing plant

Responsibilities

• Assist installation and commissioning of plant machinery.
• Qualification and documentation related to qualification of plant machinery.
• Execute and install plant equipment and monitor site execution work in project.
• Maintenance and breakdown activity related to plant equipment/machinery.
• Procure and maintain critical spares inventory.
• Update and maintain cGMP documents related to breakdown and preventive maintenance of plant machinery as per SOP.
• Supervise calibration activity and maintain related documents.
• Generate tools and parts requirement for daily breakdown and preventive maintenance.
• Carry out all work as per cGMP and GEP.
• Update and maintain all cGMP documents related to breakdown and preventive maintenance as per SOP.
• Handle quality management documents i.e., Change control, Deviation, CAPA, Quality Risk Management etc.
• Coordinate with vendors and purchase department
• Qualification and documents related to qualification of plant machinery.
• Ensure Preventive and Predictive Maintenance is carried out in coordination with concerned departments as per planner.
• Preparation and review of QMS documentation.

Skills

GDP

GEP

Aseptic maintenance

Calibration

Communication

Vendor development

Education

Diploma

BE

Job description

Job Description

• Responsible to assist installation & commissioning of plant machinery.


• Responsible for qualification & documents related to qualification of plant machinery.


• Responsible for executing and installation of plant equipment’s and monitor the site execution work in project.


• Responsible for maintenance and breakdown activity related to plant equipment / machineries.


• Responsible to procure & maintain the critical spares inventory.


• Responsible to update and maintain all cGMP documents related to breakdown & preventive maintenance of plant machinery as per SOP.


• Responsible to supervise the calibration activity and maintain the related documents.


• Responsible to generate tools and parts requirement for daily breakdown and preventive maintenance.


• Responsible to carry out all work as per cGMP and GEP.


• Responsible to update and maintain all cGMP documents related to breakdown and preventive maintenance as per SOP.


• Responsible for handling quality management documents i.e., Change control, Deviation, CAPA, Quality Risk Management etc..


• Responsible for co-ordination with vendors and purchase department


• Responsible for qualification & documents related to qualification of plant machinery.


• To ensure that Preventive and Predictive Maintenance is carried out in co-ordination with the concerned departments as per planner.


• Preparation and review of QMS documentation.

Skills

• GDP


• GEP


• Maintenance skill for aseptic area & equipment for Pharmaceuticals products


• Machine and instrument calibration


• Good communication


• Machine spares & vendor development

Qualifications

Education: Diploma/ B.E.

Total Experience - 3 - 7 Years of experience in engineering plant maintenance role for sterile manufacturing plant