Title:  Shift Maintenance Engineer

Safety:

To place safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.

Primary Responsibility:

• 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 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.
• Compliance to Syngene’ s quality standards at all times
• Hold self-accountable for the achievement of safety goals
• Govern the safety metrics from time to time

Specific Responsibilities:

• Responsible for maintaining the facility, equipment in GMP compliance state as a team member of maintenance at Biologics Manufacturing.
• Candidate shall have instrumentation back ground and hands on experience in Biologics equipmets.
• Responsible to perform the preventive maintenance activities as per schedule.
• Preparation and execution of equipment qualification (DQ, IQ, OQ) related documentations.
• Responsible to prepare the master list and planners as per the schedule.
• Planning and coordinating with vendor to carryout external AMC and equipment PM.
• Monitoring and maintaining all utilities for BMP facility during shift and day to day operations.
• Preparation of biologics EAM related SOPs related to maintenance.
• Attending the breakdowns of equipment’s for biologics.
• Identifying and maintaining the critical spares.
• Responsible for reconciliation and archival of documents.
• Providing the trainings for service providers and contract engineers.
• Responsible for clean utilities maintenance.
• Daily monitoring of HVAC parameters.
• Responsible for QMS closure. (CCF, CAPA & deviations)
• Responsible to involve in client and regulatory audits, address the audit findings.
• Responsible for preparation of quality department protocols related to EAM.
• Supporting for preparation of General procedures and standard operating procedures of EAM.
• Responsible for maintaining the BU approved layouts.
• Responsible for completing the inhouse modifications/projects.
• Responsible to perform the SAP activities.
• Responsible to maintaining and closing the complaint slips on time.
• Responsible to support for qualifying the vendors coordinating with QA.