Senior Executive - Project & Engineering (Plant Maintenance)

Amneal Pharmaceuticals LLC; Ahmedabad District; Presencial; INR 450.000 - 650.000; Jornada completa

Descripción de la vacante

Amneal Pharmaceuticals LLC is seeking an experienced Maintenance Engineer for their sterile manufacturing plant in India. The role focuses on installation, commissioning, qualification, and ongoing maintenance of plant machinery, ensuring compliance with cGMP and GEP.

The ideal candidate has 3–7 years in engineering plant maintenance and holds a Diploma or BE. Strong calibration, vendor coordination, and documentation skills are essential.

Formación

• Diploma or BE is required.
• Total experience of 3–7 years in engineering plant maintenance for sterile manufacturing.

Responsabilidades

• Assist installation and commissioning of plant machinery.
• Qualification of plant machinery and related documents.
• Execute and supervise installation at site, monitor on-going site work.
• Maintenance and breakdown activities for plant equipment/machinery.
• Procure and maintain critical spares inventory.
• Update cGMP documents for breakdown and preventive maintenance as per SOP.
• Oversee calibration activities and maintain related records.
• Generate tools and parts requirements for daily breakdowns and PM.
• Ensure all work adheres to cGMP and GEP guidelines.
• Coordinate with vendors and purchasing department.
• Plan and ensure preventive and predictive maintenance with concerned departments.
• Prepare and review QMS documentation.

Conocimientos

Maintenance

Calibration

Vendor development

Communication

Spare parts management

Educación

Diploma/ BE

Descripción del empleo

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

• 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