Responsible for overall engineering operations including site specific projects.
Ensure smooth & cost effective Operation & Maintenance of Engineering.
Prepare and maintain project cost, planning, procurement, contract and document control strategies, plans and procedures.
Managing project deliverables in line with the project plan
Working closely with users to ensure the project meets business needs
Maintenance of Process Equipment of Solid Oral manufacturing facility
Review and ensure that schedule for calibration and PM is made and executed as per the plan.
Ensure equipment availability by effective supervision and by ensuring availability of critical spares for Repairs, Preventive Maintenance & for Calibration
To initiate & Review of the QMS Modules as applicable.
To participate in Self inspections / Audits.
To review the critical breakdowns and to initiate corrective actions.
To ensure that Good Engineering Practices are implemented
Creation of Operation Procedure & Formats related engineering department and conducting the routine validation Test for HVAC system, Water system and Compressed air system.
Constantly look for energy drains such as compressed air leakages, steam leakages unnecessary running of equipment etc. And take immediate corrective and preventive actions.
Identification and development of vendor network / Contractors.
Supervise special services offered by OEM and service agencies offering annual maintenance contracts.
To train the department personnel by identifying the training needs.
Functional Experience :
Tablet & Capsule) (Fluid Bed Dryer, RMG, Shifter, Milling Machine, Coating Machine, Compression Machine Capsule Filling Machine, Blister Packing Machine.
Steam Generation & Distribution systems : Boilers & Accessories ,Steam Distribution Network & Condensate Recovery Systems
Refrigeration & HVAC System : Chillers, Air Handling Units (AHUs), Dehumidifiers , Clean Room Environment Monitoring & Control including BMS System,
Clean Utility Systems like Water treatment Plants (WTP), Purified water Generation & Distribution, Pure Steam Generators.
Other Utility Systems : Pumps, Air Compressors & Compressed Air Distribution, Nitrogen Plant, Air Dryers Cooling Towers, Blowers
Equipment, system and facility qualification Documentation.
Compliance of USFDA,MHRA,TGA,WHO-GMP and other regulatory standards
SAP PS, PM & MM
MS Projects &MS Office etc.
Desired Candidate Profile: Qualification :
B. Tech or BE (MEC)Experience :15 to 20 years Willing to relocate to Pondicherry