Job Description

Division

Department

Sub Department 1

Employment Type

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

Competencies

Cipla