Mechanical Engineer | Cipla Ltd | Goa

Job Purpose

The incumbent is a team member of the Engineering Maintenance & Reliability Team and carries overall responsibility to:

•  Execute the maintenance activities in the plant & ensure the minimum breakdown with maximum efficiency by following safety & GMP Standards
• Support Senior Engineer in carrying out Functional 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;
• Functional Engineer is responsible for executing maintenance tasks as assigned by Senior Engineer for his function in the Manufacturing, Packing, and utility areas.
• Where outsourced, 3rd Party Functional Engineer is accountable for the Service Floor / Technical Floor maintenance execution

Key Accountabilities

I.   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, and accidents. Participate in Investigations as required. Communicate across shift operations. Implement CAPA as required.
•    Conduct WPI, BOS Tours, and Internal audits of ME EHS Standards and implement CAP for effective EHS on Shop Floor.
•    Ensure statutory compliance inspection and documentation are carried out as per the 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 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 the quality tool (Cipdox, etc.). Any change to the cGMP environment should only be done with approved change control and should factor in the rias assessment recommendations.
•    Address non-conformances through deviations and implement the CAPA to maintain the 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 the risk management team i.e. Failure mode effect criticality analysis (FMECA) & draw necessary CAPA.
•    Write / Review / Evaluate change controls related to the 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 a focus on PROOFING | GHK | SUPPRESSION & INSPECTION

III.  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 & finalize 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 the PPM schedule; ensure that handing 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 minimize the impact on quality and production
o    Check that critical spares inventory of all machines is maintained to reduce resolution time
o    Follow PPM as per schedule to avoid breakdown
o    Procure, inspect and approve material from the 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 a proactive Condition Monitoring program for Unit Operations

IV.   Reliability Improvement:

•    Conduct Reliability Improvement Analysis for Unit Operations
•    Develop and maintain stoppage database for key plant & equipment. Analyze 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 utilization 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.

V.  Recommend new technologies and ensure capacity building of the Engineering Team to improve the Machine/system performance:

•    Identify the training needs of the Engineering Team member & coordinate internal and external training/ 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. 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. 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

VIII.  Operational Support the Unit Engineering Head – EM&R

•    Manage resources (in-house vs outsourced), 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 the delivery of reliability-focused CAPEX projects.

IX. Site Cost Performance:

•    Monitor cost heads with the 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 the Unit EM&R Head for review
•    Adhere to Cipla Financial Control Policies, Standards & Procedures and ensure “EFFECTIVE” status in 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.   Other Execution Accountabilities

•    Approval of requisition in SAP system.
•    Implement 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. Self Development of 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.

Major Challenges

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

Key Interactions

Internal
•    Central Engineering for technical standards and guidance
•    Finance for Capex & Opex proposal approvals, analytics & MIS
•    EHS for safe operations and near-misses
•    HR for Attrition, Recruitment, and Training
•    Site head & Unit heads for Proposals, breakdowns, and developments
•    Engineering DR for Guidance & Updates
•    Indirect purchase for Spares, scope, insurance, and new vendors
•    Central purchase for providing Technical inputs and clarifications for CAPEX
•    Global Leadership Team – Guidance & Updates in TLT, Focus Calls & Reviews
•    Corporate Affairs & Legal Team – Guidance & Updates on Compliance matters
External
•    OEMs for projects, automation, alternate vendor development, quality issues, and maintenance
•    Facility maintenance contractors to Improve maintenance and quality standards
•    Industry Bodies – Connect on external benchmarking & information on technology evolution
•    Statutory Bodies – Connect for Regulatory compliance

Dimensions

• Direct Reports: 3-5, Team Size – 9-12
• Unit Maintenance + Utility Budget: 15-20 CR [ Functional ~ 33% of this]
• Capex Budget: Sustenance 10 CR [ Functional ~ 33% of this]
• Revenue of Goa I: 300-400 CR
• Current Replacement value of Assets Maintained: Net Block > 50 CR; CRV > 200 CR

Decisions
•    Spends within Approved Budget –Capex & Opx
•    Maintenance & Reliability Strategies
•    Engineering & Project Vendors & Service Providers as per EA
•    Technology for Manufacturing
•    Resource Conservation initiatives
•    Capability Programs
Recommendations
•    Opex & Project cost Proposal
•    New vendor addition
•    Facility audits
•    Hiring consultants
•    New Equipment & Technology

Education Qualification

BE / B Tech (Mechanical)