Engineer - Instrumentation

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: 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