Job Description

Division
------------


Manufacturing Department
--------------


Active Pharmaceutical Ingredient Sub Department 1
--------------------


Engineering - API 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 Electrical 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 Electrical 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 " 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 (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 (Electrical)


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 Electrical engineering activities.