MES Lead
4 weeks ago
Job Description This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create meaningful contributions to the world. Position Overview The MES Lead will play a pivotal role in driving Manufacturing Execution System (MES) implementations across the Pharma Services Division, employing the Rockwell FactoryTalk Pharma Suite (FTPS) platform. Based at the Centre of Excellence in Hyderabad, this role will champion standard methodologies, lead standardization, and ensure compliance with global quality and regulatory requirements. It is the responsibility of the MES Lead to collaborate closely with business participants, vendors, and implementation partners in order to deliver scalable, reusable, and high-quality MES solutions with agility and efficiency. Key Responsibilities - Lead MES implementation efforts across various manufacturing facilities within PSG, applying FTPS as the primary platform. - Develop and implement the solution strategy, ensuring alignment with corporate digital manufacturing goals. - Promote the use of reusable build templates, workflows, and processes to speed up solution delivery. - Establish uniformity in functionalities, libraries, and business processes to guarantee consistency across worldwide deployments. - Work closely with vendors, system integrators, and internal Centers of Excellence teams to ensure timely, cost-effective project delivery while meeting industry standards. - Interpret business requirements to develop validated MES solutions while adhering to GxP and FDA/EMA regulations. - Ensure MES solution architecture and configurations support scalability, security, and integration with ERP, LIMS, and automation layers. - Offer practical and technical direction, support, and mentoring to project teams. - Serve as a main point of contact for resolving issues that arise during MES implementations. Compliance & Documentation - Champion MES implementation initiatives across multiple manufacturing sites under PSG demonstrating FTPS as the core platform. - Define and put into effect the plan for resolution, guaranteeing alignment with company digital manufacturing objectives. - Drive the adoption of reusable design templates, workflows, and processes to accelerate solution delivery. - Standardize functionalities, libraries, and business processes to ensure consistency across global deployments. - Partner with vendors, system integrators, and internal CoE teams to deliver projects on-time, on-budget, and in compliance with industry standards. - Translate business requirements into validated MES solutions while ensuring alignment with GxP and FDA/EMA expectations. - Ensure MES solution architecture and configurations support scalability, security, and integration with ERP, LIMS, and automation layers. - Provide functional and technical leadership, guidance, and mentorship to project teams. - Act as a key customer concern point for issue resolution during MES implementations. - Maintain detailed documentation for recipe design, configuration, and change control. Continuous Improvement - Promote continuous enhancement of MES frameworks, templates, and reusable assets for faster deployment cycles. - Lead knowledge-sharing initiatives across sites to ensure dissemination of lessons learned and standard methodologies. - Evaluate and recommend technology upgrades, new capabilities, and process enhancements. - Emphasize agility and speed-to-value without compromising quality or compliance. - Drive performance metrics for MES solution adoption, operational efficiency, and business value realization. Qualifications - Bachelor's degree or equivalent experience in Engineering, Computer Science, Life Sciences, or related field. - 10-14 years of experience in MES solution delivery within the pharmaceutical or life sciences industry. - Minimum 5 years of hands-on leadership with Rockwell FactoryTalk PharmaSuite (FTPS), including configuration, deployment, and support. - Solid background in Regulated environments with knowledge of cGMP, CSV, and regulatory compliance frameworks. - Shown success in handling multi-site MES implementations in large or global organizations. - Experience integrating MES with ERP (e.g., SAP), LIMS, and automation/SCADA systems. - Vendor management experience, particularly with Rockwell Automation and system integrators. - Track record of leading multi-functional teams and handling participant expectations. Key Proficiencies - Deep expertise in MES architecture, design, and delivery on FTPS. - Solid understanding of pharmaceutical manufacturing processes including packaging, batch execution, weigh & dispense, and eBR. - Practitioner of reusable templates, standardized processes, and solution scalability concepts. - Excellent knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and CSV standards. - Solid project management skills with the ability to lead multi-disciplinary teams. - Exceptional problem-solving, decision-making, and analytical abilities. - Good communication and participant engagement skills across technical, business, and leadership levels. - Ability to balance speed of deployment with uncompromising quality and compliance. - Passion for continuous improvement and digital transformation initiatives in Pharma manufacturing. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. - This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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