The candidate shall HOLD a Degree in relevant fields of Engineering discipline, preferably Mechanical /Process Engineering.
DUTIES AND RESPONSIBILITES
Develop and execute an engineering strategy for the site
Support manufacturing process improvement, capacity scale-up, sustaining engineering and maintenance of business, and strategic programs Provide leadership, guidance and support in technology transfers, new product launches, troubleshooting and problem resolution, capital project planning and executions, cost improvement and talent management Writing and execution of documentation like Protocols, SOP, Deviations, CCF, and events to ensure GMP compliance.
Proactive in getting all the required information from stakeholders to perform the job.
Coordination with all cross functional department for maintenance planning and effective handing over of machine/instrument after maintenance.
To review and ensure timely compliance of maintenance services to plant operation.
To plan and review the calibration activity/schedule and ensure timely compliance.
To evaluate the breakdown of equipment/instrument systems by failure analysis and implement the proper corrective and preventive measure.
To Plan Preventive maintenance of the equipment and instruments.
To prepare and ensure compliance of all cGMP and regulatory documentation related to the function.
Shall participate in CSV/PLC Validation Activity experience.
To review and ensure the compliance of safety guidelines and procedures.
To ensure and comply with the effective functioning of the environment control system.
To ensure the optimization usage of resources for the reduction of downtime.
To attend management meetings, discuss the plant engineering issues for timely compliance.
To co-ordinate with Purchase / Finance department for material, services & payments, & service agreements Planning of spares & consumables for better inventory & budgetary control as per approved norms.
Cost effective & Quality vendor development for engineering materials & services. Work with third party suppliers as and when required.
Periodically inspect the contractor jobs to ensure compliance of quality, safety and timely completion.
To check indents & contractor services bills.
Identifying and implementing improvements to reduce costs, improve reliability, safety and quality.
QUALIFICATIONS AND REQUIREMENTS
The candidate shall HOLD a Degree in relevant fields of Engineering discipline, preferably Mechanical /Process Engineering.
A minimum 8-10 years' experience in engineering management for the Pharmaceutical Industry.
Should have experience of handling/faced EUGMP, USFDA audit.
Should have exposure for Plant and Utility Maintenance of Pharmaceutical Sterile Plant.
Shall have knowledge of BMS system, PW, WFI Water System.
Shall have experience in HVAC systems, clean steam generators, boilers, chillers,
cooling towers air compressors and other ancillary equipment.
Competency in Engineering Management and technical staff development.
Strong troubleshooting and analytical capabilities with experience in Problem
Solving, 5s, Kaizen, TPM, FMEA, Lean & Six Sigma etc.
The influential leader is responsible for the technical direction of the team and ownership of the aseptic process technical competency.
Interfacing and communicating with the site and corporate leadership