This position is responsible to provide, expertise, methodology, strong organization support of the engineering department, and manufacturing department APUs in organizing and optimizing its activities.
Responsible to coordinate all Quality system related activity within the engineering department and provide ad hoc support
This includes developing & planning of Preventive Maintenance, Calibration Management, Spare parts & Engineering Warehouse management, Contract & Vendor Management, Cost optimization, O&M of Wastewater plant, Raw Water Supply & Fire hydrant systems management.
Duties & Responsibilities
Maintenance and Calibration Management (Standard and Guidelines) : Develop and establish maintenance management standards as per global practices based on gap analysis.
Develop and establish site specific maintenance KPI’s. Establish Good reporting system in co-ordination with internal stake holders.
Communicate the same with Global teams. Develop Annual Building Maintenance schedules also to be comprehensive.
FMEA Management : Perform FMEA, Annual Preventive maintenance & Calibration review & analysis, Annual breakdown review & analysis.
Maintain and report failure trends, provide updates to respective team members to improve OEE and review / revise maintenance SOPs accordingly.
Analyze maintenance work orders and engineering related for change controls, events, CAPA’s in Phenix related to Engineering services for repeated failures and propose corrective measures
Contract & Vendor Management : Sourcing & selection of competent vendors / contractors for all site engineering activities which includes AMC, ARC, CMC, O&M Contracts.
Monitor the performance & provide timely feedback to management with regards to HSE / Quality / timely completion / Housekeeping etc.
and propose development actions and penalties if necessary. Facilitate closure of department pending procurement and financial transactions in co-ordination with cross functional teams within department and report / escalate delays
Technical SLA Management : Develop, review, update / revise and manage technical SLA which includes O&M of ETP, Raw Water Supply & Sump Management, FHS pump house management as per approved SLA guidelines.
Black Utilities may be added in future)
Equipment Life Cycle & Performance Management - Develop performance requalification schedules of clean utilities, HVAC, facility, other equipment’s as per QA SOP in co-ordination with cross functional teams including external stake holders for execution and completion of the works.
as per the Matrix enclosed).
QMS Facilitator - Engg : Facilitate closure of all engineering related deviations and changes as per QMS. Provide support and interface with all stake holders internally that these are tracked & closed in timely manner and report management.
Conduct Level 1 +QDCI and ensure tracking of KPIs. Review major engg. compliance periodically.
Engg. WH Management Establish Engineering Warehouse standards and practices and ensure its compliance. Implement spare parts strategy as defined.
Coordinate with site SCM & WH leads to be in line with site WH systems & procedure, for stock and inventory audits.
Networking : Coordinate with Global engineering team to understand and implement e global engineering guidelines as applicable to site.
Other tasks assigned by HOD from time to time.
HSE (Safety) :
Collaborate with site & Global HSE and ensure all safety and environmental guidelines are adhered.
Support to maintain site specific safety goals, PASS and expectations
People Management :
Lead a team of engineers, provide an efficient and people oriented support to develop the teams and each individual.
Ensure good and efficient relations between all department to optimize plant efficiency
Provide all the relevant training that demands in specific to engineering & related GMP.
Knowledge, Skills & Competencies / Language
Should be well versed with cGMP and GEP requirements along with domestic and international regulatory requirements
Detailed knowledge of pharmaceutical quality, manufacturing operations, operations and maintenance of utility and process equipment’s
Proven ability to lead, manage and motivate people with good leader ship skills as people manager.
Act for change
Language requirements :
Ability to read, understand, write and speak in English, and Hindi.
Graduate in Engineering or equivalent
Minimum 10-12 Years’ Experience.
Requirements of the job
This position requires occasional travel as per job demand
This position requires the incumbent to be available on call 24 hours / day
This position will suit an individual who is able to operate with discretion and confidentiality about sensitive data
This position requires to adopt well to new and advance quality and engineering systems.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.