Engineer - Mechanical
Cipla · Rangpo
Division
Manufacturing
Department
Formulation
Sub Department 1
Engineering - Formulation
Job Purpose
- The incumbent is a team member of Engineering Maintenance & Reliability Team and carries overall responsibility to:
- 1. Execute the maintenance activities in the plant & ensure the minimum breakdown with maximum efficiency by following safety & GMP Standards
- 2. Support Senior 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;
- Functional Engineer is responsible for executing maintenance tasks as assigned by Senior Engineer for his function in the Manufacturing, Packing and utility areas.
- Where outsourced, 3rd Party Functional 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 maintenance activity to meet maintenance targets for a shift
- ¢ Cater to machine and facility 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 Shift Engineer report to ensure smooth shift handover
- ¢ Analyse breakdowns, diagnose faults and supervise time critical equipment repairs.
- ¢ Offer technical expertise to maintenance people like supervisor, foreman, fitters and technicians.
- ¢ Function as project development member to maintain new equipment.
- ¢ Work with reliability engineers to extend equipment life cycle.
- 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 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
Key Accountabilities (2/6)
- III. Breakdown Maintenance: Handle breakdown maintenance to avoid recurrence and maintain continuous process operations
- ¢ Execute breakdown work expeditiously but safely and in compliance with cGMP.
- ¢ Receipt and tracking the job card for the break down activity
- ¢ Maintain critical spares inventory of all machines to reduce resolution time
- 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 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.
Key Accountabilities (3/6)
- 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 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
- 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
Key Accountabilities (4/6)
- 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 documentation and timely entries in all document 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 Senior Engineer.
- ¢ Prepare and maintain engineering documents wrt cGMP and Good Engineering Practices
- 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 mechanical engineering & 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 mechanical engineering & 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 â 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 â Guidance & Updates in TLT, Focus Calls & Reviews
- ¢ Corporate Affairs & Legal Team â 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 â Connect on external benchmarking & information on technology evolution
- ¢ Statutory Bodies â Connect for Regulatory compliance
Key Interactions (2/2)
Dimensions (1/2)
- ¢ Direct Reports: 0, Team Size â 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 â 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)
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 projects
- Knowledge of GMP and various regulatory requirements
- Good leadership skills and experience in mechanical engineering activities
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