Lead - Asset Integrity & Reliability (Civil) (Medium Site)

Division

Manufacturing

Department

Formulation

Sub Department 1

Engineering - Formulation

Job Purpose

Preface: Cipla Manufacturing Assets are Aging with an average age of 20 Plus years and 75% of asset base 15 years of service and is degrading.

Asset degradation is a significant concern in Global Operations. For every easily-identifiable symptom of corrosion or asset instability, there are dozens of hidden issues: hydrogen attack, high-temperature tempering, thermal fatigue, metallurgy issues, internal system corrosion, and so on; without dedicated & experienced professionals, implementing damage mitigation techniques is next to impossible.

Asset integrity, is the term for an asset™s capacity to run effectively and accurately, whilst also protecting the wellbeing of all personnel and equipment with which it interacts ' as well as the measures in place to assure the asset™s life cycle. The key is - how to balance the designing, maintenance, and replacement of assets throughout their life cycle with the costs to business ' in terms of finance, time, and resources. At its heart, it is the managing of the degradation of assets.

Reliability engineering is a sub-discipline of systems engineering that emphasizes the ability of equipment to function without failure. Reliability engineering deals with the prediction, prevention and management of high levels of lifetime engineering uncertainty and risks of failure.

The incumbent provides functional leadership to the' Asset Integrity & Reliability and carries overall responsibility to:

• Ensure Asset Integrity & Reliability Service for Plant & Equipment covered by AI&R Program for the impact function [Civil] - helps ensure that Plant & Equipment are properly designed, installed in accordance with specifications, inspected and maintained so that it remains fit for use until it is retired]
• Assure compliance with Cipla Global E&P Technical Standards & Procedures, cGMP Standards & Procedures [ Cipla QMS] , OHS & Env Sustainability Standards & Procedures in AI&R services. Ensure statutory compliance in impact area as the Responsible Engineer.
  
  

Key Accountabilities (1/6)

I. [E] Maintain Deep Functional Knowledge as a SME to deliver the Asset Integrity & Reliability Services for the Site Operations

¢ Maintain deep functional knowledge of the foundation standards & regulations such as

• ISO
• IEC
• OGP
• API
• OSHA
• ASME
• ANSI
• Seveso II
• NACE
• ASTM
  
  

¢ Maintain Proficiency Certificate as a AI&R Practitioner

II. [E] Embed the Asset Management Process in impact function

¢ Review Asset Register and ensure that asset management standards is duly embedded and the asset register is up dated.

¢ Implementation / sustenance of AM standards of RCM, PEI, EEI, IPF, PS, ESP, CF, CP, MTA, MRP, Spare parts management, SCE management Budgeting and SMS

¢ Conduct benchmarking studies for various asset management processes &implement recommendations

¢ Implement digital format - Engineering reports and KPIs

¢ Development & Deploy Functional Engineering DEPs and Data requisition sheets

¢ Sustain / Deploy SCE management principles on site. Drive identification of safety critical equipment, performance standards, deviation management, facility status reporting.

III. [R] Implement Asset Integrity Management System: Ensure that Asset degradation is systematically identified and assessed

¢ Ensure EM&R personnel are trained in AI&R Inspection and conduct AI&R inspection as per defined checklist.

Including

• Inspection of Plant & Equipment
• Inspection of Critical Elements as per program
• Material testing as required
• Non-destructive testing as required
• Condition monitoring as stipulated.
  
  

¢ Review the above reports to systematically identify and assess the asset degradation.

¢ Arrange to obtain an independent review and verification of the findings as a frequency agreed with the Head AI&R.

IV. [E] Implement Asset Integrity Management System: Data Adequacy & Integrity

¢ Be the SPOC & Focal point of any design data for the Site Operations.

¢ Be the Focal Point for any changes in ERP data related toe Asset Management System, working closely with Global and/or Central Data and Process design owners.

¢ Ensure as Lead AI&R

• perform activities as a primary data engineer, subject matter expert, and/or lead engineer in maintenance, assurance, technical support, and standardization of technical data and documents of the operating unit, including any site engagements and leadership on technical and tools forums.
• Analyse technical data, documents, and processes for the business to align with AMS by working with engineering, maintenance, operations, and project teams and partners
  
  

Key Accountabilities (2/6)

V. [E] Implement Asset Integrity Management System: Design Review

¢ Conduct the Design Review and approve the same as the Functional Technical Authority.

¢ Ensure that the recommendations are incorporated before the installation of such equipment & systems through institutionalized reviews on Project / Procurement Stage Gates.

¢ As a SME who understand the complexities and intricacies of the equipment & maintenance activities to ensure reliable operations - by studying the operations and maintenance manuals of OEMs, general task lists, equipment specific task lists, test certificates, maintenance reports, spare part list, maintenance strategies, etc., conduct technical discussions stake holders and provide guidance on best life cycle asset integrity & reliability approach including limits of operations

¢ Ensure that recommendations from Design Review studies are built into the Asset Management Program and any CAPA tracked for completion

VI. [E] Implement Asset Integrity Management System: Reliability Centred Maintenance Studies

¢ Conduct the RCM Studies and approve the same as the Functional Technical Authority.

RCM study a reliability tool that is used to ensure the inherent designed reliability of a process or piece of equipment through the understanding and discovery of equipment functions, functional failures, failure modes and failure effects

¢ Manage stakeholders/ representatives of various operating units through effective communication and identifying & resolving the bottlenecks for data analysis, maintaining issue logs, and use the same in implementing changes/improvements in the processes

¢ Ensure that recommendations from RCM studies are built into the Asset Management Program and any CAPA tracked for completion. This includes

• RCM Findings in Plant Dossier
• RCM Recommendations in Operations & Maintenance Strategy
• Review of Obsolescence & Retirals
• Comments on significant life cycle events
  
  

Key Accountabilities (3/6)

VII. [E] Implement Asset Integrity Management System: Integrity Assessment and Residual Life studies

¢ Conduct the Integrity Assessment and Residual Life studies and approve the same as the Functional Technical Authority.

Residual life study (RLS) is a method by which the type of degradation of equipment and its materials are determined to ascertain the remaining life of the equipment

Conduct all 3 stages of RLS

• On line tests & Operational, design & historic information - review of all engineering design and operational documents, past test data to identify the common problems and prioritize which offline tests are more important in second phase
• Off-line test - Focus on those that indicate risk from Sage 1. Undertake a range of outage tests to investigate issues, and correlate with assessment from stage 1
• Classification & Recommendations ' Classify the life stage and give recommendations for life extension.
  
  

¢ Manage stakeholders/ representatives of various operating units through effective communication and identifying & resolving the bottlenecks for data analysis, maintaining issue logs, and use the same in implementing changes/improvements in the processes

¢ Ensure that recommendations from RLS studies are built into the Asset Management Program and any CAPA tracked for completion. This includes

• RLS Findings in Plant Dossier
• RLS Recommendations in Operations & Maintenance Strategy
• Review of Obsolescence & Retirals
  
  

VIII. [E] Implement Asset Integrity Management System: Conduct Risk Based Inspections on assets identified basis asset degradation reviews and RCM Studies

¢ Conduct the Risk Based Inspection and approve the findings as the Functional Technical Authority.

The RBI concept lies in fact that the risk of failure can be assessed in relation to a level that is acceptable, and inspection and repair used to ensure that the level of risk is below that acceptance limit. RBI is a decision-making methodology for optimizing inspection plans basis assessment of risk and ˜active™ and ˜potential™ damage mechanisms (DMs) to assess and rank failure probability and consequence.

• Probability of Failure (PoF) is estimated based on the types of degradation mechanisms operating in the component
• Consequence of Failure (CoF) is defined for all consequences that are of importance, such as safety, economy and environment. Consequence of failure is evaluated as the outcome of a failure based on the assumption that such a failure will occur.
• Classification of Recommendations.
  
  

¢ Ensure that the recommendations are incorporated in the Maintenance strategy of the Plant & Equipment.

IX. [E] Implement Asset Integrity Management System: Ensure that Process Safety & Security Risk Assessment are carried out

¢ Ensure that Process Safety & Security Risk Assessment are carried out by Lead AI&R Process Safety in partnership with the Functional Lead.

¢ Ensure that the recommendations are incorporated in the Maintenance strategy of the Plant & Equipment.

Key Accountabilities (4/6)

X. [E] Implement Asset Integrity Management System: Damage Mitigation

¢ Leverage AI&R Studies to predict risks of failure and incorporate recommendations in maintenance strategy.

¢ Ensure that Damage Mitigation Techniques are assessed & incorporated in maintenance strategy to assure asset™s capacity to run effectively and accurately, whilst also protecting the wellbeing of all personnel and equipment with which it interacts

XI. [E] Implement Asset Integrity Management System: The Field Connect

¢ The Lead AI&R should optimally balance the design, maintenance, and replacement of assets throughout their life cycle with the costs to business ' in terms of finance, time, and resources.

¢ Constantly engage with site EM&R leads, original equipment manufacturers, vendors and upgrade the Operations & Maintenance Strategy.

¢ Interact and communicate with the site EM&R leads and manufacturing leads on Operations & Maintenance Strategy in impact domain and make them

• understand the intricacies about how the actual maintenance activities have been planned and need to be performed.
• Understand the functions of the various equipment and instruments and also a thorough knowledge of reading/ interpreting the engineering drawings (P&IDs, PEFS, PFDs).
  
  

¢ Collaborate with MTO team to identify, prioritize, and act to mitigate threats and realize opportunities to meet the Strategic Asset Management Plan and business plan delivery.

¢ Prepare and update optimized equipment care strategies and plans for the systems within operating units and support them to sustain asset performance.

¢ To achieve business Context, Performance targets, Asset Integrity, Availability, and costs, risk-based methodologies like (RCM/RBI/SIS) are utilized to Optimize Maintenance Activities.

¢ Ensure that the Asset Register is complete for all equipment in MEC scope and maintained in a Computerized Maintenance Management System (CMMS). Defining Functional System Priority considering the Production Loss Equation, Asset, and Environment Consequences. RAM Matrix is used for this activity.

¢ Based on the prioritization of the Functional System, RCM Study is conducted using tools like w-IMS, w-RCM, etc. Equipment care tasks shall be defined and documented in a GPO approved IMS application.

¢ The Engineering disciplines shall be accountable for defining equipment care tasks and optimize them for a benchmarked competitive cost.

¢ After proper review of these risk-based recommended strategies/tasks, by AI&R Team, the same shall be updated/implemented in CMMS/SAP.

XII. [E] Ensure Continued Fitness for Purpose of assets identified under the AI&R Program

¢ As Functional Technical Authority - maintain oversight of the Plant & Equipment covered under the Asset Integrity & Reliability Services Program to ensure continued fitness for purpose through institutionalized reviews, inspections & audits of a statistically valid sample to assure oneself of the efficacy of the program.

¢ Provide formal assurance Continued Fitness for Purpose of assets identified under the AI&R Program

¢ Ensure any assed which does not meet the assurance criteria is notified and dealt with.

Key Accountabilities (5/6)

XIII. [E] Ensure that Equipment Failures and Deficiencies are addressed

¢ As Functional Technical Authority - maintain oversight of the Plant & Equipment covered under the Asset Integrity & Reliability Services Program to ensure that Equipment Failures and Deficiencies are addressed on priority.

¢ Ensure escalation where required.

XIV. [E] Compliance to Cipla Global Standards & Procedures: Technical Standards

¢ Act as the Functional Technical Authority

¢ Ensure maintenance of Proficiency Certification.

XV. [E] Compliance to Cipla Global Standards & Procedures: cGMP & QMS Standards

¢ Provide Inspection support on escalated issues

¢ Review and evaluate the risk assessment on escalated issues.

¢ Review change controls related to system, facility and document and study of impact related to changes on asset integrity and reliability.

¢ Review major deviations as per standard procedure and necessary CAPA in relation to deviation system for impact on asset integrity and reliability.

¢ Provide technical guidance with regards to Asset Integrity & Reliability to the Site Engineering & Project Teams.

XVI. [E] Compliance to Cipla Global Standards & Procedures: EHS & Env. Sustainability ' Critical & Controlled Equipment Standards & Procedures.

¢ Function as the Responsible Engineer of impact Function. As a Civil Engineer act as

• Resp Engineer ' Plant Structures & Buildings
• Resp Engineer ' Soil & Groundwater Protection
  
  

¢ Maintain oversight of the Critical & Controlled equipment management program in impact function.

XVII. [E] Statutory Compliance

¢ As the Responsible Engineer ensure compliance with statutory requirements.

• The Factories Act & Rules under its umbrella
• The Electricity Act & Rules under its umbrella
• The Explosives Act & Rules under its umbrella
• The Boilers Act & Rules under its umbrella
• Th Environment Protect Act and Rules
• National Building Code and Rules
  
  

This is not intended as a comprehensive list

Key Accountabilities (6/6)

XVIII. [E] Functional Capability

¢ As a custodian of Engineering functional capability develop strong functional capabilities through

• Basic Engineering Academy
• Sterile Engineering Academy
• Digital Academy
• Reliability Engineering Academy
• Asset Integrity and Process Safety
• Conducting trainings of users on SAP, RCM, RBI, IPF and AIM software
  
  

XIX. [E] Other accountabilities

¢ Structural stability of building structures: Check healthiness of buildings and upkeep the stability reports every 5 yrs. as a statutory requirement required by Factory Inspectorate.

¢ Maintain approved & up-to-date Site Drawings for [IDC and Factory Inspectorate]

¢ Support Project Engineering

• Guide and lead the various stages of project to achieve specific goals, objectives, and Key Performance Indicators (Planning, design, and quality) of the project.
• Facility design: Prepare layouts, BOQ & URS for proposal of New project or modification work for new equipment at site.
• Preparation of techno commercial statements for various work involved in civil project for construction work, modular partitions, epoxy work, modular interiors furniture™s, external painting work, external Piperack paintings.
• Scheduling and tracking of work as per plan during execution of work, with vendors and project team members.
• Engineering data & documentation: Ensure site readiness for regulatory audits. Ensure that there are no backlogs/deviations in the respective month against the target justified in KPI™s.
• Procurements, certifications of material procured and certifications of bills.
  
  

XX. [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.

Major Challenges

• Aging Asset with high level of Asset Degradation
• Issues around Design & Installation ' high level of difficulty in doing Risk Based Inspections
• Challenges around capability & competence of personnel and service providers
  
  

Key Interactions (1/2)

Internal

¢ Central Engineering Team ' Ensuring alignment with Global Engineering standards and procedures and best practices.

¢ Finance for Capex & Opex proposal approvals, analytics & MIS

¢ EHS for safe operations and near-misses

¢ HR for Attrition, Recruitment, Training

¢ Site head & Unit heads for Proposals, breakdowns and developments

¢ Engineering DR for Guidance & Updates

¢ 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: NIL
• Maintenance + Utility Budget: 80-90 CR
• Capex Budget: Sustenance 50-60 CR Capacity Capex ' 100 -120 CR
• Revenue of Goa I: 1400 ' 1500 CR
• Current Replacement value of Assets Maintained: Net Block 200 CR; CRV 800 CR
  
  

Dimensions (2/2)

Key Decisions (1/2)

Decisions

¢ Asset Obsolescence & Equipment Retiral

¢ Approval of Design & Choice of Plant & Equipment

¢ Approval of Maintenance & Operations Strategy

¢ Approval of competent personnel for managing critical & controlled equipment

Recommendations

¢ Opex & Project costs Proposal

¢ New Equipment & Technology

¢ New Vendor addition

¢ Facility audits

¢ Hiring consultants

Key Decisions (2/2)

Education Qualification

BE / B Tech (Civil)

Relevant Work Experience

€¢ 7-10 years of experience in engineering (Design, Maintenance, Operations and Projects). At least 3 years in senior Technical SME role

€¢ Exposure to Asset Integrity & Reliability Engineering Standards & Regulations

€¢ Hands On experience on Asset Integrity & Reliability Engineering of at least 3

€¢ 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

---