Senior Engineer - Mechanical

Job Purpose

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

Key Accountabilities (3/6)

IV. [E]Reliability Improvement:
• Conduct Reliability Improvement Analysis for Unit Operations
• Develop and maintain stoppage database for key plant & equipment. Analyse stoppage data and report equipment reliability (periodically)
• Perform root cause analysis on equipment breakdowns to determine failure modes and develop action plans
• Ensure closure of action plans as per agreed SLAs
• Mitigate risk using PHA, FMEA, FTA and CA models.
• Help in life cycle asset management by determining the life cycle cost.
• Help in performing asset utilisation analysis.
• Help in performing overall equipment effectiveness analysis.
• Help in performing remaining useful life (RLA) analysis.
• Helps in performing value analysis by giving inputs on repair/ replace and repair / redesign decisions.

Key Accountabilities (4/6)

V. [E]Recommend new technologies and ensure capability building of Engineering Team to improve the Machine/system performance:
• Identify training needs of the Engineering Team member & coordinate for internal and external trainings/ seminars to stay updated with the new techniques used in maintenance
• Conducting internal audits / Idea generation sessions to improve on deficiencies to verify GEP and GMP.
• Implement action plans for improving on deficiencies observed through internal / external audits.
• Suggest new technologies in the market for implementation in Cipla
VI. [E]Unit Turn Around Execution
• Be accountable for & drive the Unit Turnaround Plan for impact function
• Ensure delivery of the following KPMs
o TA Program Stage Gate Review Compliance
o TA Program Scope Delivery
o TA Program Timelines Delivery
o TA Program Cost Delivery
o Zero LTA in TA Execution
o Zero cGMP Incidents in TA Execution
o Zero Rework on Start Up
VII. [E]Unit Capex program execution
• Be accountable for & drive the Unit Capex Plan for impact function
• Ensure delivery of the following KPMs
o Project Stage Gate Review Compliance
o Project Scope Delivery
o Project Timelines Delivery
o Project Cost Delivery
o Zero LTA in Project Execution
o Zero cGMP Incidents in Project Execution
o Zero Rework on Start Up

Key Accountabilities (5/6)

VIII. [E]Operational Support the Unit Engineering Head - EM&R
• Manage resources (in-house vs outsource), methodologies and frequencies.
• Support ongoing skills development of EM&R Team Members
• Technical support to reliability teams (review and monitor KPIs)
• Support shutdown planning and execution
• Support process / energy improvement initiatives
• Support delivery of reliability focused CAPEX projects .
IX. [E] Site Cost Performance:
• Monitor cost heads with Unit EM&R Head and implement corrective actions to keep cost heads under control
• Identify and implement operating cost reduction initiatives
• Monitor the expenditures related to engineering activities
• Gather ideas for cost reduction initiatives and share the same with Unit EM&R Head for review
• Adhere to Cipla Financial Control Polices, Standards & Procedures and ensure "EFFECTIVE" status on Control Environment and "NO CRITICAL OBSERVATIONS" in Internal Audits through periodic institutionalized reviews / audits with the Unit Heads / Functional Heads and the Site Finance Head.
X. [E] Other Execution Accountabilities
• Approval of requisition in SAP system.
• Implement of the Master Services Agreement
• Development, approval and monitoring of suppliers of engineering materials and services for the Site
• Any other job allocated by Senior Factory Management.
XI. [E] Self Development on mechanical engineering & leadership aspects
• Keep self-updated on regulatory guidelines and product regulatory requirements of all markets to which product manufactured by the Site is exported.
• Undergo training on mechanical engineering & Leadership capability building as per guidance from HR function and the Global Operations Team.

Key Accountabilities (6/6)

Major Challenges

• CapEx and OpEx – Adherence to the budget
• Cost vs performance trade off in equipment
• Ageing Asset leading to escalating OpEx Cost
• Challenges around capability & competence of personnel and service providers

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