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21/08 Vyshnav Kp
HR Manager at Cohire

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Engineering Manager - Pharma/Chemical Industry (12-20 yrs)

Mumbai Job Code: 40676

Key Accountabilities:

Accountability Cluster Major Activities / Tasks:

- Design/ Engineering and Site Support - Responsible for providing project support of small and medium Control system upgradation and revamp project.

- Support the site for the URS and align as per DEP and DRS requirements.

- Review the final URS and Vendor offer for the correctness and value engineering.

- Develop and implement the best practice guidelines on CONTROL SYSTEM design and engineering complying to safety relevant to pharma Industry. Harmonize Control System design and engineering practices across all sites. Ensure best practice guidelines are suitably implemented by all sites in projects.

- Implement cGMP, GxP and US-FDA requirement and review existing system for compliance.

- Develop a Life Cycle Management of existing and new systems and align the site team for managing Obsolescence of control system hardware and software.

- Align the control system with OT/ IT engineer for upkeeping of control system layers for efficient operation.

- Review of CER of Control System Projects for small and medium projects.

- Phase out plan to be prepared with Roadmap and blueprinting for the control system project.

- Drafting of URS and Other validation documentation in alignment with CQA and Site execution team.

- Support the site for control system project planning, scheduling and CSV validation (IQ and OQ)

- To connect Vendors for better coordination and Stronger vendor relationships.

- Help the sites for the competency assessment of Vendor personnel assigned for AMC.

- Governance and Track of Control System project which includes project management with monitoring and tracking the project execution across location to meet the defined timeline. Be responsible in all aspects for the Technical Delivery.

- Manage the Control System Projects work plan via weekly, monthly, and quarterly status that would help identify the issues.

- Support to Unit technical team to resolve the ongoing challenges with Vendors and trouble shooting.

Control System Knowledge:

- Develop OEM specific (Siemens PCS 7, Emerson Delta V, Rockwell Automation Micrologic/ Compact Logic/ PlantPAx, ABB 800xA etc) system design, architecture, IO segregation, documentation and BOQ.

- Bring harmonization of architecture and OT layers Enterprise Level.

- Co-ordinate with the Central IT/ OT team, Data Scientists and Data Translators to govern and maintain the system in Healthy state.

- To access competency level at site and identify training requirement (internal/ external) across Sites.

- Skill development & enhancement sessions for Site teams.

- Exploring and deployment of the new cutting-edge technology from OEMs.

- Capability Development - Be a trainer in various Engineering academies.

- Coordinate various sessions from industry experts, OEMs, consultants on various topics and advancement related to the discipline.

- Encourage and assist in the development of all control system engineers within Professional Services.

- Develop and implement focused training module for control system engineers.

Major Challenges:

- The sites have various Control Systems from different manufacturers.

- Harmonization of systems considering Cipla preferred architecture and design engineering practices.

- Competency issue with Vendor personnel leading to AMC issue and ineffective CAPA. Current issues with Control System Vendor Management and timely support.

- Control system upgradation project management and delay in schedule.

- New Technology selection issues due to inadequate assessment, ownership complication, business continuity, and internal capability to handle after implementation.

- Control System Obsolescence management and yearly budget planning for the system upgradation/ retrofit etc.

- End to end automation concept may lost while designing the project.

- Key backbone and interface between the users, IT team, Quality, Procurement and vendors.

- Automation Capex Tracking and budgeting.

- Regulated and Automation Guidelines adherence.

Key Interactions:

Internal External:

- Co-ordination with Control System Engineers/ Asset Integrity Engineers, site team and site engineering heads.

- Presentations to senior management.

- Working with Cross Functional Teams. - Co-ordination with external consultants, specialists and Auditors.

- Co-ordination with Control System Vendors, System Integrators, etc.

Key Decisions:

- Decisions Recommendations

- Vendor Assessment on technical aspects

- Knowledge of Control System

- AMS

- DCS/ PLC/ SCADA/ OPC UA

- Compliance Knowledge

- Regulatory - 21CFR Part 11 compliance, ALCOA +

Control System Engineer:

- To support the sites for URS, System Architecture and offer review

- To support manufacturing sites for the troubleshooting and upkeeping of Control Systems

- Optimize unbudgeted expenses

- Evaluation and implementation of new technology

Skills & Knowledge:

Educational qualifications:

- Graduated from Instrumentation & Controls or Telecommunication, Engineering, or any related faculty with advanced analytics courses certified.

- Previous experience in Pharma API or Chemical Industry in charge on the DCS, RTUs, PLC, SCADA and Safety System in particular the candidate has to be familiar with Rockwell Automation PaX, Siemens PCS S7, Honeywell Experion, Schneider, Emerson Delta V, ABB 800xA Control System (Original Manufacturer of DCS, RIO, PLC and Safety System).

- Knowledge of system integration and development of architecture.

- Knowledgeable on understanding and preparation of technical documents like design basis, specifications, System Architecture, IO List/ Segregation, Network drawings, control philosophy/ control strategy interpreting technical drawings, P&I diagram, cause and effect matrix, alarm trip summary, HAZOP, LOPA, loop diagrams, wiring diagrams, electrical control schematics, and various flow charts.

Relevant experience:

- At least 12 ~ 15 year of experience in Engineering roles preferably in Pharma/ Chemical Industry.

- Ability to implement new techniques, development of automation practices deep understanding of Automation projects, integration with third party systems (DCS, SCADA, OPC, BMS etc), Advance Control System Design, Troubleshooting, planning and organizational skills, prioritization multi-tasking, understanding of financial concepts like CAPEX, OPEX etc., knowledge of CSV guidelines, GxP, cGMP, National and Internation standards.

- Leadership role supporting multiple small to mid-sized green field and brown field projects

- Knowledge of Electrical would be an asset/preferable.

- Previous site experience will be an asset.

- Familiar with digital tools, digitization and data acquisition experience are an asset.

- Extensive working knowledge of Control System deliverables such as:

- System Architecture, Network Diagram etc.

- Panel (JB and Marshalling) Design

- Loop Drawings

- Wiring Drawings

- Good understanding Motor Control Schematics, IRP, iMCC, PCC, Numeric Relays interconnections, VFDs

- Protocols used for various purpose and communication networks like profibus, foundation fieldbus, CAN BUS, Ethernet, Modbus, ISA, Profinet, V-New, Modbus TCP etc.

- FAT/ SAT

- Hardware and Software Specifications (Datasheets)

- I/O Lists, IO Loading, IS Calculation

- DCS/ SIS Logic Development

- Bill of Materials

- Control Narratives, Control and Shutdown Philosophy

- Material Requisitions/ Specification

- Construction or Engineering Work Packages.

- Conversant with national and international Standards like ISO, ISA, IEC, IEEE, cGMP, etc.

- Demonstrated capabilities in leading the Control System design and engineering work in multiple and concurrently small and medium projects.

- Competent use of relevant software such as MS Office Suite.

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