Lead Maintenance Engineer

Role: Lead Maintenance Engineer

Job Location:

Department: Engineering & Maintenance

About Syngene:

Job Purpose:

Common Responsibilities:

Responsible for EAM activities in the Biologics Operations Unit

Ensuring all assigned mandatory trainings related to data integrity, health and safety measures are completed on time.

Specific Responsibilities:

Leading engineering and maintenance team for GMP areas at Biologics Manufacturing and Biologics Process Development.

Able to handle minor project, design review and execute and Facility modification in a GMP facility.

Exposure in handling Process, Electrical, HVAC, Utilities and instrumentation teams.

Ensuring the related facility, equipment and maintenance systems are in GMP compliance state.

Adherence to established procedures and policies of the company on Quality and Safety, ensuring the team adheres the same.

Responsible for managing maintenance activities within framework of Quality management systems. Ensuring work management through defined SOP s, Change control, deviations and CAPA, review and approval through Trackwise and EDMS.

Represent the function during audits and ensuring agreed actions are acted upon timely.

Ensure followings are complying:

o Equipment master list, Preventive Maintenance and calibration planners are prepared timely.

o Preventive maintenance and Calibration of equipment and facility are executed as per the planner.

o Qualification of equipment and facility and area validation for GMP blocks as per schedule.

o Operations and maintenance of Utilities to enable operations

o Service contracts for equipment and Instruments are planned and executed.

Ensure that team comprising of on-roll engineers and contract manpower are trained on GMP requirements. Evaluation, assessment and selection of vendors for providing services for maintenance, calibration and validation

Overall maintenance management that includes handling unscheduled breakdowns and other general upkeep activities are as per requirement to enable operations.

Identifying and maintaining Inventory of equipment spares required for maintaining continuous operations.

Reviewing and analysing the energy and utility consumption like electricity units, water etc. and take measures for control. Implementing the energy saving initiatives.

Facility design, detail engineering and execution of any new requirements for business growth.

Preparing and presenting the MIS reports

Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company procedures, internal and external customers with respect to quality, service, lead time and cost.

Good exposure in Regulatory audit handling.

Educational Qualification:

Technical/functional Skills:

Responsible for EAM activities in the Biologics Operations Unit

Ensuring all assigned mandatory trainings related to data integrity, health and safety measures are completed on time.

Develop and contribute to development of procedures, practices and setup that ensures safety operations compliant to company and regulatory norms.

Leading engineering and maintenance team for GMP areas at Biologics Manufacturing and Biologics Process Development.

Able to handle minor project, design review and execute and Facility modification in a GMP facility.

Ensuring the related facility, equipment and maintenance systems are in GMP compliance state.

Experience:

Equal Opportunity Employer: