DivisionManufacturingDepartmentActive Pharmaceutical IngredientSub Department 1Engineering - APIJob PurposeThe incumbent is a team member of xc3xa2xc3x82xc2x80xc3x82xc2x9c 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 executionKey Accountabilities (1/6)I. Shift Maintenance Activity: Execute maintenance activities in a shift by managing available resources to achieve shift maintenance plan.
xc3x82xc2xa2 Execute assigned tasks as per planned Instrumentation & Automation maintenance activity to meet maintenance targets for a shift
xc3x82xc2xa2 Cater to machine maintenance requirements of Unit as a responsible member of the team with overall ownership of Unit Operations.
xc3x82xc2xa2 Increase the efficiency of area by ensuring better utilization of equipment and by reducing downtime in manufacturing area
xc3x82xc2xa2 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.
xc3x82xc2xa2 Schedule shift activities in line with the CMP including PM, Calibration, and condition monitoring activities.
xc3x82xc2xa2 Execute planned Instrumentation & Automation maintenance and update related documentation
o Preventive Maintenance
o Calibration
o Condition Monitoring
o Planned Corrective Actions
xc3x82xc2xa2 Follow good Engineering practices during planned preventive activity.
xc3x82xc2xa2 Perform validation, qualification and calibration as per schedule and update output of all activities in the systems
xc3x82xc2xa2 Prepare new documents and update existing documents as per GMP requirement
xc3x82xc2xa2 Update Metrics on Schedule compliance
III. Breakdown Maintenance: Handle breakdown maintenance to avoid recurrence and maintain continuous process operations
xc3x82xc2xa2 Execute Instrumentation & Automation breakdown work expeditiously but safely and in compliance with cGMP.
xc3x82xc2xa2 Receipt and tracking the job card for the break down activity
xc3x82xc2xa2 Maintain critical Instrumentation & Automation spares inventory of all machines to reduce resolution timeKey Accountabilities (2/6)IV. Efficient Equipment Operation: Operate the equipment efficiently without error and deviation as per SOP to meet shift targets
xc3x82xc2xa2 Operate an equipment only when trained and authorized to do it.
xc3x82xc2xa2 Perform unit operations as per SOP & unit processes as per work instructions
xc3x82xc2xa2 Maintain equipment, facility and block premises as per SOP for audit readiness. Ensure equipment, facility and block premises are maintained as per regulatory compliance
xc3x82xc2xa2 Ensure all operations are performed as per GMP & Safety norms by reviewing all processes and documents for compliance
xc3x82xc2xa2 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
xc3x82xc2xa2 Implement new technologies in the plant initiated by management
xc3x82xc2xa2 Attend planned trainings and incorporate the learnings on the floor for improving machine performance
xc3x82xc2xa2 Implement and close ideas generated through internal audits / Idea generation sessions
xc3x82xc2xa2 Monitor present energy use of the plants to identify and report areas for energy conservation
xc3x82xc2xa2 Implement Energy Conservation activities to improve the equipment efficiency, reduce error and reduce production cost
xc3x82xc2xa2 Identify areas of improvement in instrumentation functoin for waste & work simplification
xc3x82xc2xa2 Manage activities to operate within budget and to reduce operating expenses
xc3x82xc2xa2 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
xc3x82xc2xa2 Issue required Instrumentation & Automation materials (spares and consumables) to the contractors from stores and make SAP entries for the receipts and issuance
xc3x82xc2xa2 Maintain the inventory of critical spares and consumables by tracking consumption and monitoring of stocks
xc3x82xc2xa2 Assess log book requirements, raise the request to QA and issue them within required timelines
xc3x82xc2xa2 Classify the unused / spare / usable scrap materials or components and reuse the same where ever possibleKey Accountabilities (3/6)VII. EHS Compliance: maintain high level of Safety during maintenance to avoid major breakdown and report accidents/ incidences
xc3x82xc2xa2 Complete preplacement Safety Training before starting the work in any area.
xc3x82xc2xa2 Monitor safe operations of the machine as per SOP and timely report any safety deviations
xc3x82xc2xa2 Maintain proper procedures for safety permits in plant Ensure safety systems and procedures followed by the operators in the shift
xc3x82xc2xa2 Issue work permits to contractual staff after verifying the safety aspects, monitoring and communicating safety hazards and safety near miss to the concern.
xc3x82xc2xa2 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
xc3x82xc2xa2 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
xc3x82xc2xa2 Attend safety meetings and ensure implementation of actions planned during departmental safety meeting at shop floor
xc3x82xc2xa2 Ensure compliances to safety training targets by monthly reconciling attendance records
VIII. cGMP Compliance: Execute and update online documentation to meet cGMP requirements
xc3x82xc2xa2 Complete preplacement cGMP Training before starting the work in any area.
xc3x82xc2xa2 Monitor cGMP compliance in the impact domain and report any incident / cGMP deviation to the Shift In charge as well as the Senior Engineer.
xc3x82xc2xa2 Maintain online instrumentation documentation and timely entries in all documents in cGMP environment and their supporting documents
xc3x82xc2xa2 Check documentation before submission to ensure data integrity. In case of any deficiency or errors in documents and rectify them as per SOP
xc3x82xc2xa2 Conduct training related to cGMP, equipment operation, safety and housekeeping for workmen
xc3x82xc2xa2 Optimize the use of resources in housekeeping; Ensure good housekeeping and sanitisation as per the guidelines
xc3x82xc2xa2 Operate software such as SAP, CipDox and QMS as required and basis training & certification.
xc3x82xc2xa2 Execute CAPA as guided by the Instrumentation Senior Engineer.
xc3x82xc2xa2 Prepare and maintain engineering documents wrt cGMP and Good Engineering PracticesKey Accountabilities (4/6)IX. Continuous Improvements: Provide suggestions for optimization of processes to manufacture quality product
xc3x82xc2xa2 Propose and implement new idea to enhance production, optimise the use of consumable goods and maximum utilization of resources
xc3x82xc2xa2 Provide new ideas and simplify processes to reduce process cycle time and achieve new targets
xc3x82xc2xa2 Participate in internal audits / Idea generation sessions to improve on deficiencies to verify GEP and GMP.
xc3x82xc2xa2 Implement action plans for improving on deficiencies observed through internal / external audits
X. [E] Self Development on functional & leadership aspects
xc3x82xc2xa2 Keep self-updated on regulatory guidelines and product regulatory requirements of all markets to which product manufactured by the Site is exported.
xc3x82xc2xa2 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
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