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

DivisionManufacturingDepartmentFormulationSub Department 1Engineering - FormulationJob PurposePreface: 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 assets 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 assets 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 [Instrument] - 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 asISOIECOGPAPIOSHAASMEANSISeveso IINACEASTM¢ Maintain Proficiency Certificate as a AI&R PractitionerII. [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 reportingIII. [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.IncludingInspection of Plant & EquipmentInspection of Critical Elements as per programMaterial testing as requiredNon-destructive testing as requiredCondition 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&Rperform 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 partnersKey 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 completionVI. [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 includesRCM Findings in Plant DossierRCM Recommendations in Operations & Maintenance StrategyReview of Obsolescence & RetiralsComments on significant life cycle eventsKey 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 equipmentConduct all 3 stages of RLSOn 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 phaseOff-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 1Classification & 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 includesRLS Findings in Plant DossierRLS Recommendations in Operations & Maintenance StrategyReview of Obsolescence & RetiralsVIII. [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 componentConsequence 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 assets capacity to run effectively and accurately, whilst also protecting the wellbeing of all personnel and equipment with which it interactsXI. [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 themunderstand 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 Instrument Engineer act asResp Engineer " CIPSResp Engineer - SIL¢ 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 umbrellaThe Electricity Act & Rules under its umbrellaThe Explosives Act & Rules under its umbrellaThe Boilers Act & Rules under its umbrellaTh Environment Protect Act and RulesNational Building Code and RulesThis is not intended as a comprehensive listKey Accountabilities (6/6)XVIII. [E] Functional Capability¢ As a custodian of Engineering functional capability develop strong functional capabilities throughBasic Engineering AcademySterile Engineering AcademyDigital AcademyReliability Engineering AcademyAsset Integrity and Process SafetyConducting trainings of users on SAP, RCM, RBI, IPF and AIM softwareXIX. Other Accountabilities¢ Project SupportSterile units line integration SCADA project.Cipla digital journey " Project PegasusSystem upgradation with latest operating trendObsolescence Management and Digitalization21 CFR compliance, manual equipment database to automatic backup.Energy conservation using cloud-based algorithms¢ Escalated Issues ResolutionTroubleshooting of hardware/software issues; VFD programming; PLC hardware/software knowledge.Identify the root cause and modify the instrument if required.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 ChallengesAging Asset with high level of Asset DegradationIssues around Design & Installation " high level of difficulty in doing Risk Based InspectionsChallenges around capability & competence of personnel and service providersKey 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 mattersExternal¢ 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 complianceKey Interactions (2/2)Dimensions (1/2)Direct Reports: NILMaintenance + Utility Budget: 80-90 CRCapex Budget: Sustenance 50-60 CR Capacity Capex " CRRevenue of Goa I: 1400 " 1500 CRCurrent Replacement value of Assets Maintained: Net Block > 200 CR; CRV > 800 CRDimensions (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 equipmentRecommendations¢ Opex & Project costs Proposal¢ New Equipment & Technology¢ New Vendor addition¢ Facility audits¢ Hiring consultantsKey Decisions (2/2)BE / B Tech (Instrumentation)Education Qualification7-10 years of experience in engineering (Design, Maintenance, Operations and Projects). At least 3 years in senior Technical SME roleExposure to Asset Integrity & Reliability Engineering Standards & RegulationsHands On experience on Asset Integrity & Reliability Engineering of at least 3Ability to implement new techniques, deep understanding of manufacturing process, planning and organizational skills, prioritization multi-tasking, understanding of financial conceptsGood technical knowledge of Pharma / API machinery and utility requirementsGood knowledge and experience in execution of green field / brown field projectsKnowledge of GMP and various regulatory requirementsGood leadership skills and experience in industrial automation