Senior Engineer - Mechanical (68965)

Requisition ID 68965

The incumbent provides leadership to the Unit Engineering Maintenance & Reliability Team and carries overall responsibility to:
1. Ensure Mechanical EM&R Planning, Detailed Scheduling and Execution of CMP to- ensure continuity of availability of plant & equipment at optimal cost; achieve standard capacity; ensure overall plant & equipment integrity & reliability - in compliance with Cipla Policies, Standards & Procedures; Reporting of EM&R MIS, Incidents & Deviations @ SOP;
2. Anchor the Reliability Improvement Analysis and improvement initiatives for the function.
Senior Mechanical Reliability Engineer is accountable for his function in the Manufacturing, Packing and utility Area.
Where outsourced, 3rd Party Senior Mechanical Reliability Engineer is accountable for the Service Floor / Technical Floor maintenance execution

Key Accountabilities (1/6)

I. [E] Implement & Maintain Interdependent Safety Culture [ This is a multidisciplinary line job and hence safety takes priority]
• Implement and Maintain a safety culture with zero reportable and LTA (Loss Time Accident)
• Implement ME Priority standards
o Permit to Work [ Including LOTOTO]
o Chemicals Handling [ Incl. Health & Hygiene]
o Contractor Safety
o Critical & Controlled Elements
o PPE
o Incident Reporting & Investigations
• Ensure that any change to Plant Assets & Equipment is only done after the due approval for Plant Modification Authorization / Change Control. An implementation factors the recommendations from the Risk Assessment document for the change authorization.
• Report all near misses, incidents, accidents. Participate in Investigations as required. Communicate across shift operations. Implement CAPA as required.
• Conduct WPI, BOS Tours, Internal audit of ME EHS Standards and implement CAP for effective EHS on Shop Floor.
• Ensure statutory compliance inspection and documentation are carried out as per approved checklist and documented.
• Check all safety interlocks of Critical Machines are checked as per sop
• Review points of safety meetings and implement actions planned of departmental safety meeting
• Implement proper procedures for safety permits with Engineers & contractors.
• Resource Conservation Initiatives in the Unit as agreed with the Leadership Team
II. [E]cGMP
• Ensure that facility maintenance complies with cGMP norms & GEP during maintenance execution.
• Review, approve and track of QMS tools to maintain quality matrix
• Plan, execute and submit to QA compliances related to regulatory audits
• Plan and execute major, minor and moderate changes using quality tool (Cipdox etc.). Any change to cGMP environment should only be done with approved change control and should factor the rias assessment recommendations.
• Address non-conformances through deviations and implement the CAPA to maintain quality score matrix
• Keep the facility upgraded as per current GMP requirements
• Ensure / conduct validation & calibration as per the Master Validation & Calibration Schedule.
• Review and evaluate the risk assessment along with risk management team i.e. Failure mode effect criticality analysis (FMECA) & draw necessary CAPA.
• Write / Review / Evaluate change controls related to system, facility and document and study of impact related to changes and to ensure implementation of change.
• Initiate / Review major deviations as per standard procedure and necessary CAPA in relation to deviation
• Own & drive the Integrated Pest Management Program in the impact area with focus on PROOFING | GHK | SUPPRESSION & INSPECTION

Key Accountabilities (2/6)

III. [E]Maintenance Execution:
• Implement the Comprehensive Maintenance Program for the Function in the Unit Operations. Review Unit CMP planner & review adherence to planned preventive maintenance & instrument calibrations across the Unit for effective maintenance and adherence to standards
o Gather the Unit Engineers and prepare the PPM/Calibration schedule
o Distribute machine group amongst the Engineers as per schedule
o Analyse individual unique planners by Engineers & finalise PPM / Calibration planner
o Ensure that Engineers follow good engineering & cGMP practices during planned preventive activity
o Check & review engineering documentation post completion for meeting the cGMP and Good Engineering Practices
• Provide ongoing technical support to EM&R Team Members including any Asset Integrity & Reliability Inspections / Audit
• Assess and handle breakdown maintenance to avoid recurrence and maintain continuous process operations by maintaining critical parts availability and adherence to PPM schedule; ensure that hand back the Asset under maintenance is done with due compliance to Cipla Policies, Standards & Procedures. Identify any essential Asset replacements / retirals
o Attend and review breakdown, scheduled work and its completion to minimise impact on quality and production
o Check that critical spares inventory of all machines are maintained to reduce resolution time
o Follow PPM as per schedule to avoid breakdown
o Procure, inspect and approve material from engineering store
• Implement and achieve Best Practice Standards in terms of Maintenance Execution and Maintenance Productivity KPMs such as
o Wrench Time
o PM to CM Ratio
o CM due to PM
o Open Notification past Due dates
o Asset Hierarchy & Register Completeness
o SAP CMMS Usage
o Tier-1 Leaks per month
o Tier-2 Leaks per month per unit
o Average Time to repair leaks (hrs)
o Temporary repairs per unit
• Comply with maintenance execution work processes
• Ensure the proper, timely and safe implementation of preventive and corrective maintenance activities
• Ensure critical spares of critical m/c are maintained to reduce resolution time by predicting demand and reviewing availability
• Maintenance execution is documented as per the Cipla Global Standards & Procedures.
• Drive proactive Condition Monitoring program for Unit Operations

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Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory disease, cardiovascular disease, arthritis, diabetes, depression and many other medical conditions.