Senior Specialist Shift Maintenance

Job Title: Shift Maintenance Engineer

Job Location: Bangalore

Job Level: Experienced

About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific  services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Role Accountabilities:

• Adherence to the EHSS procedures as per Syngene policy.
• Responsible to initiation/closure of the synzero observation
• Adherence to Engineering Standard Operating Procedures and safety requirements
• Preparation of Preventive Maintenance SOPs for EAM-related maintenance activities.
• Ensuring compliance with quality systems.
• Efficient handling/maintenance and troubleshooting of Drug substance equipment-Autoclave, Fermenter, Shaker Incubator Single use bioreactors, Tangential flow Filtration, Chrome system, Chromatography column and TCU’s
• Efficient handling/maintenance and troubleshooting of Drug product equipment’s-Vial Washing Machines, Sterilization Tunnel, Sterilization Tunnel, Automatic Vial Sealing machines. Automatic Visual inspection machines. Compounding and filtration vessels.
• Efficient handling/maintenance and troubleshooting of QCM equipment’s
• Efficient handling/maintenance and troubleshooting of Warehouse equipment’s 
• Efficient handling/maintenance and validation of cold storage equipment’s
• Efficient handling/maintenance/troubleshooting and validation of Bio safety cabinet, pass box, Air shower, Celling suspended Laminar airflow, vertical laminar air flow.
• Responsible to perform the preventive maintenance/AMC as per the Schedule.
• Preparation and execution of equipment qualification SLIA, URS, FAT, DQ, CLIA, QRM, SAT, IQ, OQ & support for PQ.
• Preparation and execution of Utility gases qualification, validation, requalification activities as per the schedule.
• Responsible to prepare the master list and planners as per the schedule.
• Monitoring and maintaining all utilities for the DS/DPP/QCM/Warehouse facility during shift and day to day operations.
• Identifying and maintaining the critical spares.
• Responsible to perform the scheduled maintenance as per the Schedule.
• Ensuring all assigned mandatory training related to data, integrity, health, and safety measures are completed on time.
• Compliance to current good manufacturing practices and GxP.
• Responsible for maintaining and closing the complaint slips on time.
• Supporting to QMS team for online document closure.
• Responsible for completing the in-house modifications/projects.
• Accountable for ensuring audit compliance and supporting the cross-functional team (CFT) in preparing for client visits
• Responsible for preparing of annual Preventive maintenance and Breakdown summary report.

Secondary Responsibilities: -

• Operation and maintenance of HVAC system.
• Execution/Supporting for the AHU qualification and re-qualification activity.
• Supporting/trouble shooting for the EMS/BMS monitoring system
• Operation and maintenance of electrical distribution panel.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience
2. Demonstrated Capability
3. Education

Education: BE/B.Tech/Diploma

Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, 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