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 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
- 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 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
- 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 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
