Life sciences MES Engineer

Job description

As a quality and compliance expert, you will be responsible for ensuring that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle. Therefore, you stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO. Depending on your role and expertise, you may be asked to provide Quality & Compliance support during audits and inspections, or to join a Sopra Steria validation service team. We are seeking a highly motivated MES (Manufacturing Execution System) Engineer to join our team. As an MES Engineer, you will be responsible for implementing, maintaining, and optimizing our MES to ensure efficient production processes. You will play a key role in configuring the system, providing support to users, and ensuring compliance with industry regulations. Additionally, you will drive process improvements and play a crucial part in system validation. Implementation and Configuration : Install, configure, and customize MES software to meet production needs. Collaborate with cross-functional teams to integrate MES with other systems (ERP, PLC, SCADA, etc.). System Maintenance and Administration : Perform system maintenance, troubleshooting, and updates to ensure optimal performance. Manage user accounts, permissions, and ensure data integrity and security within the MES. Validation and Compliance : Develop and execute validation plans and protocols to ensure compliance with industry standards and regulatory requirements (e.g., GAMP, FDA). Maintain detailed validation documentation, test results, and reports. Process Optimization : Analyze production processes and workflows, identify inefficiencies, and implement improvements through MES automation. Work with production teams to implement best practices and optimize system use. Support and Troubleshooting : Provide technical support for MES users and resolve any system-related issues. Conduct user training and ensure adherence to best practices for system use. Project Management : We’re seeking passionate colleagues who are eager to push the boundaries in digital transformation and technology consulting. At Sopra Steria, you’ll have the opportunity to grow your skills in a constructive, collaborative team environment, working on impactful projects that drive change for our clients. If you thrive on challenge and meet (most of) the qualifications below, we look forward to your application! Bachelor’s or Master degree in a scientific area 2-5 years of experience working with MES systems in a manufacturing environment. Strong technical skills in MES implementation, configuration, and troubleshooting. Or experience in recipe building in MES systems Familiarity with integration of MES with ERP, PLC, SCADA or DeltaV systems is a plus Knowledge of validation processes and regulatory requirements (GAMP, FDA, etc.). Excellent problem-solving skills and attention to detail. Ability to work effectively in a cross-functional team environment. Strong communication skills, both written and verbal Experience with specific MES software (e.g., Siemens SIMATIC IT, Rockwell FactoryTalk, Werum PAS-X, etc.). Previous experience in the pharmaceutical, automotive, or food & beverage industries. Knowledge of Lean Manufacturing and Six Sigma principles is a plus Project management experience or certification (PMP, PRINCE2) is a plus. What we can offer you? You’ll become a part of a major Tech player in Europe recognized for its consulting, digital services, and software development. We have a long track record. Sopra Steria’s Life Science & Healthcare team currently provides more than 100 expert Life Science consultants, organized in 3 different practices: Laboratory, Production and Business Technology. This position is an excellent opportunity for a technically skilled MES engineer who is passionate about improving manufacturing processes and ensuring compliance in a high-performance production environment. Join us and be a part of our innovation journey! Are you ready to further develop your career? Then we'd love to point you in the right direction. With offices in more than 30 countries, that direction might lead you to places you've never been to before. Would you prefer to grow internally? That's possible, too. We challenge you to keep pushing yourself to become the best you can be. We offer a generous employee benefits package that includes: A variety of perks, such as mobility options (including a company car), insurance coverage, meal vouchers, eco-cheques, and more. Continuous learning opportunities through the Sopra Steria Academy to support your career development. The opportunity to connect with fellow Sopra Steria colleagues at various team events. Ready to take the next step? We’re here to support you all the way and we are looking forward to you application! ______ Sopra Steria is an equal opportunity employer. All qualified applicants will be considered for employment without regard to age, ancestry, nationality, color, family or medical leave, gender identity or expression, genetic information, immigration status, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran or military status, race, ethnicity, religion, gender (including pregnancy), sexual orientation or any other characteristic protected by applicable local laws, regulations and ordinances. We foster a work environment that is inclusive and respectful of all differences. Sopra Steria offers tailored, end-to-end corporate technology and software solutions to help clients make bold choices and deliver results. Successfully so! With more than 51.000 colleagues in 30 countries, we rank as Europe’s leading digital solutions provider. Some of the most successful companies in Europe rely on our technology due to our commitment to innovation, collaboration, and value in business development. The world is how we shape it. Let’s shape it together.