Preventive maintenance engineer

JOB DESCRIPTION

Job Title: Preventive Maintenance Engineer

Job Location: S18 Formulation

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

• To place safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.
• Overall adherence to safe practices and procedures of oneself.
• Contributing to the development of procedures, practices and systems that ensure safe operations and compliance with the company’s integrity & quality standards.
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace always.
• Ensuring safety of self and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always 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 always
• Hold self-accountable for the achievement of safety goals
• Govern the safety metrics from time to time.

Work as team member in PSM module for companywide Kavach initiation.

Core Purpose of the Role:

• Responsible to Implement strategic initiative: Map & develop the solution as a part of infrastructure requirements & design plan in line with 1-3-5 plan.
• Responsible to Ensure “Best in Class” design implementation to deliver a safe productive environment.
• Responsible to Work with procurement to ensure vendors deliver the very best in terms of project execution, timeliness, quality of materials and costs.
• Responsible for managing a project schedule and reporting back to the management regularly on the progress of expansion and roll out.
• Responsible to attend FAT of equipment’s & Automation systems.
• Co-ordination with the vendor for qualification activities at Syngene facility (Biocon Park).
• Responsible for performing the preventive maintenance activities as per the schedule.
• Responsible for performing the activities related to the Engineering and maintenance at S18 Utility, warehouse, FDL, ADL, Formulation OSD area, Formulation-Injectable Facility and A1-FDC.
• Responsible for GMP compliance and error free operations.
• Responsible for Preparation and execution of equipment qualification (DQ, IQ & OQ).
• Responsible for performing the HVAC validation, re-qualification activities as per the schedule.
• Responsible to prepare master list and planners as per the schedule.
• Planning and coordinating with the service provider to carry out external HVAC and maintenance activity.
• Responsible for the Operation and maintenance of all utilities during shift and day-to-day operations.
• Adherence to standard operating procedures, safety, cGMP, QMS.
• Planning and execution of maintenance of equipment and its accessories.
• Manage strict SLAs in the insourced and outsourced activities- agree performance metrics with various department and deliver consistently against them.
• Ensure higher standard of safety while execution of a maintenance task, ensure complete vendor compliance to the internal safety standards. Run a consequence metrics for non-compliance of EHSS framework for vendors and employees.
• To face clients, regulatory & statutory audits in GMP area’s
• Disaster Management for equipment and control systems.
• Preparing the QMS supportive documents.

Role Accountabilities

Need to take care of the maintenance activity related to formulation (S15 GPP & A1-FDC)

Routine preventive maintenance & breakdown maintenance activity.

Preparation of SOP drafts related to equipment, master list & maintenance plan.

Preparation & execution of qualifications & re-qualifications & co-ordination with CFTs for the final review & approval.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience: 4-6 years
2. Demonstrated Capability: Capable in troubleshooting & handling of OSD equipment , analytical equipment& utility.
3. Education: ITI/ Diploma/ BE (Electrical/ Mechanical)

Experience

4-6 Years

Skills and Capabilities

Good knowledge on handling & troubleshooting of OSD equipment’s (FBE, RMG, compression & blister packing machine) & utility equipment’s like (AHUs, Chiller, Chilled & hot water pump).

Work as a team and have a collaborative mindset.

Good communication skills.

Education

ITI/Diploma/ BE (Electrical / Mechanical)

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 accommodation for qualified individuals with disabilities.