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4.0 - 8.0 years
0 Lacs
pune, maharashtra
On-site
The Manufacturing Execution Systems (MES) Consultant position is a full-time role dedicated to offering consulting services to clients within the biotech and pharmaceutical industries. As an MES consultant, you will collaborate with project teams to support MES implementation and maintenance. Your responsibilities will span across different phases of the software development life cycle, encompassing tasks like creating design specifications, recipe authoring, configuration, programming/scripting, project management, software validation, and unit testing. Effective communication and collaboration with both internal team members and external stakeholders are crucial aspects of this role. To excel in this position, you should possess a robust background in computer programming and be well-versed in MES software packages like Honeywell POMS/POMSnet, Werum PAS-X, Rockwell ProPack Data, Camstar, SAP ME, or Emerson Syncade. A minimum of 4-5 years of relevant work experience is required. Familiarity with the software development life cycle, including gathering user requirements, software code development, and test protocol execution, is essential. Proficiency in SQL queries and database concepts is a must, while knowledge of C#, VB, VB.Net languages is desirable but not mandatory. The role may involve travel to client sites within India and overseas, as necessary, and a willingness to embrace career development and feedback for future job growth is expected. Qualifications for this position include a Bachelor's degree in Science, Pharma Operations, Computer Science, Engineering, or Business Administration (BSc/MSc/BPharm/MPharm/BCA/BCS/MCA/BE/BTech/BBA/MBA). This position is based in Pune, India, with travel requirements of up to 100% based on client location.,
Posted 1 day ago
3.0 - 8.0 years
4 - 8 Lacs
Pune
Work from Office
Project Role : Software Configuration Engineer Project Role Description : Implement the configuration management plan as directed by the Configuration Lead. Assist in the design of software configuration and customization to meet the business process design and application requirements. Must have skills : Manufacturing Engineering MES Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead for Packaged Application Development, you will be responsible for leading the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve utilizing your expertise in Manufacturing Engineering MES to ensure the successful delivery of projects. Roles & Responsibilities:-Well versed with ITIL and be able to handle Incidents, Problems, and Changes for MES, quickly resolving critical issues (P1/P2) and implementing changes.-Collaborate closely with business teams to understand needs and refine solutions.-Tackle complex technical and operational challenges effectively-Set up and roll out MES software, including Linux Docker applications.-Provide expert support, troubleshooting, and deep analysis for MES apps, especially on Linux and Werum PAS-X. Professional & Technical Skills: -Experience with Werum PAS-X, including end-to-end implementations, upgrades, and migrations, and daily operations in a Linux environment.-Strong skills in installing, deploying, and troubleshooting Linux Docker, Openshift or Kubernetes.-Hands-on experience with configuration and troubleshooting MES peripherals like Scales, Printers, Scanners, PASX2X adapters, and MSI/DCS Batch Adapters.-Ability to diagnose and troubleshoot SNET, firewall issues, and application performance problems related to network configurations.-In-depth understanding of the Pharma Industry, including GxP compliance.-Good working knowledge of Oracle databases and postgress.Mandatory Skills: -Werum PASX or any other MES pharma-Linux based Docker or Openshift or Kubernetes.-Oracle / Postgress DB experience-ITIL Management-Experience of L2/L3 support Additional Information:- The candidate should have a minimum of 3 years of experience in Manufacturing Engineering MES.- A 15 years full-time education is required.- This position is based out of multiple locations. Qualification 15 years full time education
Posted 5 days ago
8.0 - 13.0 years
1 - 6 Lacs
Hyderabad
Work from Office
Job Title: Pharma Manufacturing Process Analyst / Manufacturing Systems Specialist Job Summary: We are seeking a skilled Manufacturing Systems Analyst with strong domain expertise in pharma manufacturing processes and experience working with pharmaceutical manufacturing systems (MES, SCADA, DCS, Historian systems, etc.). The role involves review and analysis of manufacturing data, including audit trail reviews , alerts , and alarms monitoring , to support digital operations and ensure regulatory compliance. Key Responsibilities: Act as a functional SME for pharma manufacturing processes , providing process insights to support system operations and investigations. Review and analyze audit trail data generated from manufacturing systems to ensure data integrity and compliance with ALCOA+ principles. Perform periodic review of alerts , alarms , and exception logs as part of routine monitoring and deviation investigations. Collaborate with production, QA, and IT teams for resolution of issues related to manufacturing systems. Support the digitization and continuous improvement initiatives in manufacturing areas. Participate in system validations, including URS development, system configuration reviews, and functional testing. Prepare and maintain SOPs and system documentation related to manufacturing systems usage and monitoring. Train end-users on manufacturing systems functionalities and regulatory requirements. Required Skills and Qualifications: Strong understanding of pharma manufacturing processes (Batch Processing, Equipment Usage, Environmental Monitoring, etc.). Hands-on experience working with Pharma Manufacturing Systems (MES, DCS, SCADA, Historian platforms). Good knowledge of audit trail review and interpretation of manufacturing system logs. Understanding of alerts , alarms , and deviation data as part of electronic record review. Familiarity with data integrity guidelines (21 CFR Part 11, EU Annex 11, WHO TRS). Experience in handling system compliance documentation (SOPs, URS, validation reports). Ability to collaborate effectively with QA, Manufacturing, and IT stakeholders. Preferred Qualifications: Knowledge of GAMP 5 , CSV principles, and pharma regulatory requirements. Experience in data review from systems like Siemens Simatic, Emerson DeltaV, Rockwell Automation, PAS-X, or similar MES/DCS platforms . Exposure to Industry 4.0 and digital transformation initiatives in manufacturing.
Posted 5 days ago
3.0 - 8.0 years
13 - 22 Lacs
Hyderabad, Pune, Bengaluru
Hybrid
Hiring for MES Engineer Location : PAN India Notice Period : Immediate to 90 Days Role & responsibilities Vice Request and Knowledge Management Master Batch Record Design Batch Execution Record Shop Floor Order Manufacturing Order User Access Management Printer Terminal Profile Configuration Equipment Master Data L2 Integration SAP KP Info SCADA OSIPI and Scales Printer Application Server Architecture Rights Management Control Data Change and Problem Management Running update SQL query in DB Application Installation Hot Fix Installation Procedure and methods 1 Experience with MES PASX Application 2 Hands on experience L4 support for PASX Application 3 Ability to perform L3 bug fixes with advanced troubleshooting skills 4 Ability to perform deeper analysis to solve the Issues Incidents 5 Ability to solve P1P2 tickets 6 Ability to find the Root Cause and Preventive Action 7 Ability to fulfill the client requirements 8 Ability to implement the complex changes in Application 9 Ability to implement the complex changes in application servers 10 Troubleshooting and solving the L2 Integration issues SAP KP Info SCADA OSIPI and Scales Printer 11 Ability to perform patching activity 12 Dealing with Vendor Windows DB Linux Citrix teams 13 Ability to review and approve the Periodic Activities 14 Create Modify of GUIRights Management 15 Ability to approve the change request related to application 16 Ability to perform the update SQL query in DB 17 Performing Application Installation with Vendor 18 Performing Hot Fix Installation and Executing the testings 19 Ability to support RFP activities 20 Analysis the tickets to improve the MTTR SLA of the incidents and service requests 21Ability to run Query and SQL knowledge If interested, please share your resume to pramoth@ltimindtree.com
Posted 1 week ago
9.0 - 10.0 years
15 - 22 Lacs
Halol
Work from Office
Hi, We are having an opening for Manager IT-MES & L2 project coordinator at our Halol/Baska(Gujarat) location. Job Summary : We are seeking a seasoned professional with 7-9 years of experience in the pharmaceutical industry, including hands-on expertise in Manufacturing Execution Systems (MES) and L2 integration. The Site Project coordinator for MES Implementation will be the primary coordinator for all MES-related activities at the Halol / Baska sites. This role demands dedicated full-time support to the project to ensures smooth execution, alignment with the global MES strategy, and timely delivery of milestones to enhance manufacturing efficiency, compliance, and digital transformation. The role will work closely with internal teams including QA, IT, SAP, business users, and L2 integrations as well as external vendors and infrastructure leads. Responsibilities include stakeholder management, managing project timelines, risks, and dependencies, ensuring infrastructure readiness, facilitating change management, and maintaining compliance with site validation and quality standards. As the single point of contact for MES implementation at the site, the site coordinator plays a critical role in driving collaboration and successful deployment. The ideal candidate will ensure adherence to global regulations (FDA 21 CFR Part 11, EU GMP, GAMP5) Previous experience with Werum (Korber Pharma) for pharma industry is a big plus Areas Of Responsibility : Project Coordination: Lead and coordinate all MES implementation activities at the site, ensuring alignment with the global MES strategy. Stakeholder Management: Serve as the single point of contact for site-level stakeholders, including QA, QA IT, IT, SAP, and business users (Production & Engineering) Vendor & Partner Collaboration: Work closely with MES vendors, infrastructure teams, and integration partners to ensure smooth execution. Timeline & Risk Management: Manage project schedules, track milestones, identify risks, and implement mitigation plans. Infrastructure & Readiness: Ensure site infrastructure (network, servers, systems) is ready and validated for MES deployment. Compliance & Validation: Oversee adherence to site quality standards, IT validation (CSV), and regulatory requirements. Communication & Reporting: Maintain clear and timely communication with the Global Project Manager and other stakeholders; provide regular updates and escalate issues as needed. Change Management: Facilitate change control processes and support user readiness and adoption. Educational Qualification : Bachelors degree in Engineering, Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. Preferred: Masters degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Project Management, Operations Management, Industrial Automation, or Pharmaceutical Technology. Specific Certification : PMP for structured project execution (Preferred) GAMP5 or CSV Training for compliance in regulated environments Experience : 9 to 10 years of experience managing IT or digital transformation projects, preferably in pharmaceutical manufacturing. Hands-on experience with MES platforms, L2/PLC systems, and SAP integration and Edge Cloud IoT. Proven track record in project planning, stakeholder coordination, and cross-functional team leadership. Strong background in GxP compliance, CSV, and validation protocols (IQ/OQ/PQ). Experience working on the shop floor and with QA, IT, and business teams in a regulated environment. Skill (Functional & Behavioural): Functional: Strong project management expertise in IT/digital systems, Knowledge of MES platforms, L2/PLC systems, and SAP integration, Familiarity with GxP, CSV, and validation protocols (IQ/OQ/PQ), Understanding of pharmaceutical manufacturing processes and shop floor operations, Proficiency in stakeholder coordination and cross-functional collaboration Behavioral: Strong communication and interpersonal skills, Proactive problem-solving and risk management, High attention to detail and compliance mindset, Ability to work under pressure and manage multiple priorities, Team-oriented with a focus on collaboration and accountability Additional Skills: (Good to have) Knowledge of data analytics tools Edge Cloud deployment experience with (IoT and and IIoT) L2 integration with MES MES integration with SAP Understanding of network and databases
Posted 1 week ago
3.0 - 7.0 years
1 - 5 Lacs
Bengaluru
Work from Office
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days arethe same. This role involves the development and application of engineering practice and knowledge in defining, configuring and deploying industrial digital technologies (including but not limited to PLM and MES) for managing continuity of information across the engineering enterprise, including design, industrialization, manufacturing and supply chain, and for managing the manufacturing data. - Grade Specific Focus on Digital Continuity and Manufacturing. Develops competency in own area of expertise. Shares expertise and provides guidance and support to others. Interprets clients needs. Completes own role independently or with minimum supervision. Identifies problems and relevant issues in straight forward situations and generates solutions. Contributes in teamwork and interacts with customers.
Posted 1 month ago
15.0 - 20.0 years
17 - 22 Lacs
Pune
Work from Office
Project Role : Software Development Lead Project Role Description : Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills : Manufacturing Engineering MES Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead for Packaged Application Development, you will be responsible for leading the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve utilizing your expertise in Manufacturing Engineering MES to ensure the successful delivery of projects. Roles & Responsibilities:-Well versed with ITIL and be able to handle Incidents, Problems, and Changes for MES, quickly resolving critical issues (P1/P2) and implementing changes.-Collaborate closely with business teams to understand needs and refine solutions.-Tackle complex technical and operational challenges effectively-Set up and roll out MES software, including Linux Docker applications.-Provide expert support, troubleshooting, and deep analysis for MES apps, especially on Linux and Werum PAS-X. Professional & Technical Skills: -Experience with Werum PAS-X, including end-to-end implementations, upgrades, and migrations, and daily operations in a Linux environment.-Strong skills in installing, deploying, and troubleshooting Linux Docker, Openshift or Kubernetes.-Hands-on experience with configuration and troubleshooting MES peripherals like Scales, Printers, Scanners, PASX2X adapters, and MSI/DCS Batch Adapters.-Ability to diagnose and troubleshoot SNET, firewall issues, and application performance problems related to network configurations.-In-depth understanding of the Pharma Industry, including GxP compliance.-Good working knowledge of Oracle databases and postgress.Mandatory Skills: -Werum PASX or any other MES pharma-Linux based Docker or Openshift or Kubernetes.-Oracle / Postgress DB experience-ITIL Management-Experience of L2/L3 support Additional Information:- The candidate should have a minimum of 3.5 years of experience in Manufacturing Engineering MES.- A 15 years full-time education is required.- This position is based at multiple locations. Qualification 15 years full time education
Posted 1 month ago
10.0 - 17.0 years
19 - 30 Lacs
Hyderabad
Work from Office
Context Sanofi strategic direction is to standardize processes across sites, to embrace the digital transformation of its Manufacturing & Supply perimeter, looking at the opportunity to simplify its current solution landscape and leverage advanced technologies to bring business value. In that context, the MARS program aims to implement the Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). The MARS (MES Accelerated Roadmap @ Sanofi) program will transform Sanofi plants, improving compliance, cost and cycle time performance. Over the last 3 years, Sanofi has deployed 30 Production sites across 4 GBUs (multiple and different pharmaceutical processes, 18 Weighing & Dispensing & 12 full MES), and a second wave, should start in the coming years (> 50 production sites, pending business case confirmation). This represents a strategic opportunity for an Manufacturing & Supply Transformation to: Design standardized end-to-end processes to generate business value for Manufacturing & Supply and deliver best-in-class solutions to our industrial sites, with a high focus on electronic batch record management (content, execution) & review by exception process; Deliver innovative "state of the art" tools enabling performance for manufacturing processes across the industrial affair sites; Allow new generation of deployment more Agile & business centric Maintain robust and highly available solutions to operate industrial processes efficiently About the job The Digital MES Deployment & Integration Expert ensures the optimal performance of MES systems and Platforms by delivering solutions tailored to business needs. This role plays a central part in the deployment and evolution of Sanofi’s MES Core Model across industrial sites. Main responsibilities: End to end responsibility to install, configure, and update Industrial sites MES Digital systems and Platforms. Provide high-level of support, coordination, and communication to Industrial sites projects, maintain documentation, and drive continuous improvement. Contribute to the evolution towards an innovative MES Standard by leveraging AI, Cloud services and DevOps tools. Optimize MES performance and monitoring through development and automation initiatives. Occasionally, it may be required to perform the installations / updates over the weekend depending on the industrial site requirements. Share knowledge and foster digital skills development within the MES domain. This cross-functional role involves close collaboration with industrial sites, digital teams, infrastructure, cybersecurity, and external partners. The expert stays up to date with internal standards, industry best practices, and emerging technologies, while also contributing to the optimization of digital maintenance processes and tools. MES Scope: MES Solutions Siemens MES Opcenter Execution Pharma Product Koerber MES PAS-X Product Technical landscape: Cloud technologies & DevOps tools Kubernetes Windows Server Oracle Prostgre SQL CitrixAzure services Ansible Mendix C# - Power-shell – VB – PL/SQL End-to-end pharmaceutical manufacturing process Production & Work Instruction Execution Traceability & Genealogy Weighing & Dispensing Integration with ERP, SCADA, LIMS, WMS, Labeling, OEE, Data Platforms Recipe & Batch Management Quality Control & Compliance (GxP) Real-time Monitoring & Performance Tracking Automation & Digital Maintenance Support About you Experience : 5+ years of experience in the Digital Manufacturing Execution System (MES) domain within the pharmaceutical industry, with a strong interest in upskilling on emerging technologies and enhancing MES technical capabilities and Industrialization, or 5+ years of experience with Cloud technologies and DevOps tools, driving automation, scalability, and system reliability/Industrialization, with a strong interest in upskilling in the functional MES domain. Soft skills : Strong focus on value delivery, with the ability to work autonomously on solution design and take ownership and leadership within the assigned scope. Proven ability to work effectively in large-scale multicultural, multilingual, and matrixed organizational environments. Solid understanding of manufacturing processes in pharmaceutical plants, with strong knowledge of GxP regulations. Agile methodology practitioner Knowledge of reporting tools (Power BI) MES Solutions Technical skills : Siemens MES Opcenter Execution Pharma MES Product Koerber MES PAS-X MES Product Cloud technologies & DevOps tools Kubernetes Windows Server Oracle Prostgre SQL CitrixAzure services Ansible Mendix C# - Power-shell – VB – PL/SQL Education : Engineering or Masters in Computer Science or related field (or equivalent experience) Languages : English Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Posted 1 month ago
5.0 - 9.0 years
10 - 14 Lacs
Bengaluru
Work from Office
Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Manufacturing Engineering MES Good to have skills : Linux Minimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. You will be responsible for overseeing the entire application development process and ensuring its successful implementation. This role requires strong leadership skills and the ability to collaborate effectively with cross-functional teams. Roles & Responsibilities: Expected to be an SME, collaborate and manage the team to perform. Responsible for team decisions. Engage with multiple teams and contribute on key decisions. Provide solutions to problems for their immediate team and across multiple teams. Lead the effort to design, build, and configure applications. Act as the primary point of contact for application-related matters. Oversee the entire application development process. Ensure successful implementation of applications. Well versed with ITIL process and should be able to handle MES support project Must show ability to create conceptual and detailed designs of MES Global template Provide design guidance to developers and testers as an integrated part of an agile scrum process Must show competence in ability to problem solve and work through complex situations Must be able to configure and deploy MES software applications and systems Ability to support, maintain, and enhance deployed software solutionsProfessional & Technical Skills: Must To Have Skills:Proficiency in Manufacturing Engineering MES. Good To Have Skills:Experience with Linux. Should have exposure in PAS-X Hot fixes implementation by using docker and container. Must Have Implementation and upgrading/Migrating skills on Dockers, should be able to install and deploy Linux Docker application. Must Have Troubleshooting skills on Linux Dockers/Containers, Werum PASX. Must Have strong experience in Linux Kernal solutions, Docker Swarm, Kubernetes, Oracle RDBMS. Must have worked on Peripheral configurations and Troubleshooting skills on Scales, Printers, Scanners, PASX2X adapters, MSI/DCS Batch Adapters. Must be able to understand and troubleshoot SNET, firewall issues, understand network related issues with respect to performance of the application. Should be able to understand the errors and troubleshoot issues related to MBR, GMBR, MO (Manufacturing Orders), PASX administration. Should be able to understand all errors of central logs, RabbitMq errors, Docker Logs, all service logs on the docker environment. Must have skills on PASX MO process, PASX control screens, should be able to co-ordinate with shop floor user errors and communicate in technical terms. SAP IBIS knowledge to understand the IDOC processing. Must have Strong hands-on to RHEL environment, Dockers and Kubernetes. Should have Pharma Industry Knowledge IQ/OQ Process. Knowledge about shop floor functional processes & Industry standards (ISA95/88) Knowledge of MES (Manufacturing Execution System) & MO (Manufacturing Operations) concepts and systems Must have worked on PAS-X administrative track like system administration, report & labels, Track & trace, data historian. Should be able to perform Database refresh activities, should have hands on experience of oracle schemas, Migration. Should have worked on process development, track and trace, finite scheduling, KPIs, MSI Knowledge of Pharmaceutical business process:Chemicals -WD, Solid bulk Mfg, packaging and other unit operations; Bio Pharma processesAdditional Information: The candidate should have a minimum of 5 years of experience in Manufacturing Engineering MES. This position is based at our Bengaluru office. A 15 years full-time education is required. Qualification 15 years full time education
Posted 2 months ago
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