Title:  Lead Maintenance Engineer

Role: Lead Maintenance Engineer

Job Location: Bangalore

Department: Engineering & Maintenance

About Syngene: Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose: Leading EAM team & activities at SU3. Execute maintenance and Upgradation projects. Ensures Safety & GMP compliance at SU3.

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.

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

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: BE/BTech in Mechanical or Electirical or Instrumentation.

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: 15 years or above within Biologics manufacturing plant, with at-least 6-7 years of experience in Leading Engineering team, Projects & Maintenance.

Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities