Responsible for Compounding Process and Associated/Supporting Equipments (Super Skids, CIP/SIP Skids, Filtration Skids and Parts Washer)
To plan and execute installation and commissioning of super skid 2 and other compounding activities.
To participate actively in qualification activities & be responsible for closure till OQ and also support PQ and trouble shoot maintenance and process related issues from time to time.
Provide support to technology transfer projects. Develop and review technical documentation URS, DQ, FAT, SAT, IQ and OQ, lead to participate and execute commissioning and qualification in all developmental projects
Develop/review MCL, PFD, P&ID, and Specifications for process equipment of compounding/formulation process equipment and their control system
Ensure facilities operational conditions, safety, GMP compliance, and asset protection in order to satisfy internal customers
Ensure closure of all QMS activities in timely manner related to process equipment is to close in time like SOPs. Training, Phenix, Geode+ from engineering perspective.
Develop/Review Equipment maintenance SOPs Responsible for Spares, consumables, preventative & breakdown maintenance
Manage (Develop, plan, review, indent and procure) requirement of all spare parts and consumables of all compounding and other process equipment as required to ensure equipment / facility availability all the time and to avoid down time for want of spares.
Repetitive failures are analysed and corrective actions implemented to avoid the same in coordination with team.
Ensure that all maintenance and engineering activities are carried out in safe and in compliance with GMP / established procedure.
Identify, evaluate, plan and execute actions and suggestions which improve productivity, safety compliance and help in resource /energy conservation. HSE
Collaborate with site & Global HSE and ensure all safety and environmental guidelines are adhered to his areas of work.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Production/Manufacturing/Maintenance
Role: Service/Maintenance Engineer
Employment Type: Permanent Job, Full Time