Engineer - Instrumentation

Division

Manufacturing

Department

Formulation

Sub Department 1

Engineering - Formulation

Job Purpose

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

• Execute the maintenance activities in the plant & ensure the minimum Instrumentation & Automation breakdown with maximum efficiency by following safety & GMP Standards
• 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 handoverII. 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

• Preventive Maintenance
• Calibration
• Condition Monitoring
• 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 complianceIII. 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 operationsV. 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 estimatesVI. 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

• Near Miss
• Safety Incident
• Work Place Inspection
• Unsafe Act
• 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 recordsVIII. 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 auditsX. [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