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Engineer - Instrumentation

Posting Date:  May 23, 2025
Department:  Active Pharmaceutical Ingredient
Business Unit:  Manufacturing
Country:  India
State:  Karnataka
Location:  Bangalore
Req Id:  92558

Division

Manufacturing

Department

Active Pharmaceutical Ingredient

Sub Department 1

Engineering - API

Job Purpose

The incumbent is a team member of “ Unit Engineering Maintenance & Reliability Team and carries overall responsibility to:
1.Execute the maintenance activities in the plant & ensure the minimum Instrumentation & Automation breakdown with maximum efficiency by following safety & GMP Standards 
2.Support EM & R Senior Instrumentation 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; 
Instrumentation Engineer is responsible for executing maintenance tasks as assigned by Senior Engineer for his function in the Manufacturing & Packing Area.
Where outsourced, 3rd Party Instrumentation Engineer is accountable for the Service Floor / Technical Floor maintenance execution

Key Accountabilities (1/6)

I.    Shift Maintenance Activity: Execute maintenance activities in a shift by managing available resources to achieve shift maintenance plan.
¢    Execute assigned tasks as per planned Instrumentation & Automation maintenance activity to meet maintenance targets for a shift
¢    Cater to machine maintenance requirements of Unit as a responsible member of the team with overall ownership of Unit Operations.
¢    Increase the efficiency of area by ensuring better utilization of equipment and by reducing downtime in manufacturing area
¢    Prepare and submit Instrumentation shift engineer report to ensure smooth shift handover 
II.    Comprehensive Maintenance Plan Execution: Give inputs for preparing & adhere to unique planner for planned preventive maintenance & instrument calibrations for effective maintenance and adherence to standards.
¢    Schedule shift activities in line with the CMP including PM, Calibration, and condition monitoring activities.
¢    Execute planned Instrumentation & Automation maintenance and update related documentation
o    Preventive Maintenance 
o    Calibration
o    Condition Monitoring
o    Planned Corrective Actions
¢    Follow good Engineering practices during planned preventive activity.    
¢    Perform validation, qualification and calibration as per schedule and update output of all activities in the systems
¢    Prepare new documents and update existing documents as per GMP requirement
¢    Update Metrics on Schedule compliance
III.    Breakdown Maintenance: Handle breakdown maintenance to avoid recurrence and maintain continuous process operations
¢    Execute Instrumentation & Automation breakdown work expeditiously but safely and in compliance with cGMP. 
¢    Receipt and tracking the job card for the break down activity 
¢    Maintain critical Instrumentation & Automation spares inventory of all machines to reduce resolution time 

Key Accountabilities (2/6)

IV.    Efficient Equipment Operation: Operate the equipment efficiently without error and deviation as per SOP to meet shift targets    
¢    Operate an equipment only when trained and authorized to do it.
¢    Perform unit operations as per SOP & unit processes as per work instructions
¢    Maintain equipment, facility and block premises as per SOP for audit readiness. Ensure equipment, facility and block premises are maintained as per regulatory compliance
¢    Ensure all operations are performed as per GMP & Safety norms by reviewing all processes and documents for compliance 
¢    Maintain system integrity by updating documentations and deviations on CipDox while performing operations
V.    New Technology / Capex: Use new technologies initiated by Management while adhering to CAPEX and OPEX targets to improve Machine/system performance
¢    Implement new technologies in the plant initiated by management
¢    Attend planned trainings and incorporate the learnings on the floor for improving machine performance
¢    Implement and close ideas generated through internal audits / Idea generation sessions 
¢    Monitor present energy use of the plants to identify and report areas for energy conservation
¢    Implement Energy Conservation activities to improve the equipment efficiency, reduce error and reduce production cost
¢    Identify areas of improvement in instrumentation functoin for waste & work simplification
¢    Manage activities to operate within budget and to reduce operating expenses
¢    Verification of the contract invoices and making of the job orders as per estimates
VI.    Spares Management: Perform Material and Spare management and issue Consumables, spares, materials, log books etc. to avoid delays due to unavailability of materials
¢    Issue required Instrumentation & Automation materials (spares and consumables) to the contractors from stores and make SAP entries for the receipts and issuance
¢    Maintain the inventory of critical spares and consumables by tracking consumption and monitoring of stocks
¢    Assess log book requirements, raise the request to QA and issue them within required timelines
¢    Classify the unused / spare / usable scrap materials or components and reuse the same where ever possible

Key Accountabilities (3/6)

VII.    EHS Compliance: maintain high level of Safety during maintenance to avoid major breakdown and report accidents/ incidences
¢    Complete preplacement Safety Training before starting the work in any area.
¢    Monitor safe operations of the machine as per SOP and timely report any safety deviations
¢    Maintain proper procedures for safety permits in plant Ensure safety systems and procedures followed by the operators in the shift
¢    Issue work permits to contractual staff after verifying the safety aspects, monitoring and communicating safety hazards and safety near miss to the concern.
¢    Ensure availability and usage of PPEs in the shift by coordinating with EHS department for requirements and shift schedule; Ensure usage and maintenance of PPEs by self & other workmen during shifts
¢    Report any safety incident to the Shift In charge as well as the Senior Engineer for the following
o    Near Miss
o    Safety Incident
o    Work Place Inspection
o    Unsafe Act
o    Unsafe Condition
¢    Attend safety meetings and ensure implementation of actions planned during departmental safety meeting at shop floor
¢    Ensure compliances to safety training targets by monthly reconciling attendance records
VIII.    cGMP Compliance: Execute and update online documentation to meet cGMP requirements
¢    Complete preplacement cGMP Training before starting the work in any area.
¢    Monitor cGMP compliance in the impact domain and report any incident / cGMP deviation to the Shift In charge as well as the Senior Engineer.
¢    Maintain online instrumentation documentation and timely entries in all documents in cGMP environment and their supporting documents
¢    Check documentation before submission to ensure data integrity. In case of any deficiency or errors in documents and rectify them as per SOP
¢    Conduct training related to cGMP, equipment operation, safety and housekeeping for workmen
¢    Optimize the use of resources in housekeeping; Ensure good housekeeping and sanitisation as per the guidelines
¢    Operate software such as SAP, CipDox and QMS as required and basis training & certification.
¢    Execute CAPA as guided by the Instrumentation Senior Engineer.
¢    Prepare and maintain engineering documents wrt cGMP and Good Engineering Practices

Key Accountabilities (4/6)

IX.    Continuous Improvements: Provide suggestions for optimization of processes to manufacture quality product
¢    Propose and implement new idea to enhance production, optimise the use of consumable goods and maximum utilization of resources
¢    Provide new ideas and simplify processes to reduce process cycle time and achieve new targets
¢    Participate in 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 
X.    [E] Self Development on functional & 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 Functional & Leadership capability building as per guidance from HR function and the Global Operations Team.

Key Accountabilities (5/6)

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

Key Interactions (1/2)

Internal
¢    Central Engineering for technical standards and guidance
¢    EHS for safe operations and near-misses 
¢    Site head & Unit heads for Proposals, breakdowns and developments 
¢    Indirect purchase for Spares, scope, insurance and new vendors
¢    Central purchase for provide 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 , automations, alternate vendor development , quality issues and maintenance 
¢    Facility maintenance contractors for Improve maintenance and quality standards 
¢    Industry Bodies “ Connect on external benchmarking & information on technology evolution
¢    Statutory Bodies “ Connect for Regulatory compliance

Key Interactions (2/2)

Dimensions (1/2)

  • Direct Reports: 0, 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

Dimensions (2/2)

Key Decisions (1/2)

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 costs Proposal
¢    New vendor addition 
¢    Facility audits 
¢    Hiring consultants 
¢    New equipment & Technology

Key Decisions (2/2)

Education Qualification

BE / B Tech (Mechanical / Electrical / Instrumentation)

Relevant Work Experience

  • 2-5 years of experience in manufacturing (Maintenance and Projects).
  • Ability to implement new techniques, deep understanding of manufacturing process, planning and organizational skills, prioritization multi-tasking, understanding of financial concepts
  • Good technical knowledge of Pharma / API machinery and utility requirements
  • Good knowledge and experience in execution of green field / brown field project
  • Knowledge of GMP and various regulatory requirements
  • Good leadership skills and experience in industrial automation

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