Engineer - Instrumentation - Summerville, United States - Cipla South Africa

Description

The incumbent is a team member of â 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
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
V
III

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)

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)

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 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 / Electrical / Instrumentation)
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

#J-18808-Ljbffr