Strategy & Consulting - Global Network - Industry X - MES Functional Specialist

Descrizione del lavoro:

Join Our Global Consulting Network and Expand Your Horizons!

Are you ready to take your career to new heights? At the Global Network, we are more than just a team; we are a thriving community of over 10,000 professionals operating from key locations around the world. We specialize in providing top-tier consulting expertise across various industries and functional areas, including life sciences, energy, supply chain operations, finance, and talent management.

Why Choose Us?

Global Exposure: Work on international projects and gain invaluable insights into diverse cultures and business practices.
Specialized Development: We don't just work across broad spectrums; we ensure you develop deep expertise in specific areas of management consulting, enhancing both your professional value and expertise.
Dynamic Work Environment: Our work is fast-paced and challenging, pushing you to grow quickly and continuously improve. It's not just about meeting expectations; it's about exceeding them and making a significant impact.
Innovation at the Core: At the Global Network, innovation isn't just a buzzword-it's a fundamental part of how we operate. We leverage cutting-edge technologies and innovative strategies to solve complex problems and deliver novel solutions that keep our clients ahead in a rapidly changing world.
We are driven by a commitment to excellence and a passion for delivering results that matter. If you are ambitious, talented, and ready for a challenge, we want to hear from you. Reach out, join our network, and start a conversation that could lead to your next big opportunity.

Let's build a better future together!

The MES Functional Specialist plays a critical role in implementing and supporting Manufacturing Execution Systems (MES) for clients in regulated industries such as pharmaceuticals and biotech. This role bridges business requirements and technical solutions, ensuring compliance with GMP and other regulatory standards while optimizing manufacturing processes.

Key Responsibilities

Requirements Gathering & Analysis
* Collaborate with business stakeholders to capture functional requirements for MES solutions.
* Conduct AS-IS and TO-BE process analysis for manufacturing workflows.

System Design & Configuration
* Design and configure MES functionalities, including:
* Electronic Batch Records (EBRs)
* Recipe authoring and management
* Equipment and material management
* Develop functional specifications and ensure alignment with business needs.

Integration & Validation
* Support integration between MES and ERP systems (e.g., SAP) and automation layers (e.g., DeltaV).
* Prepare and execute validation protocols (IQ/OQ/PQ) in compliance with GAMP5 and FDA regulations.

Testing & Deployment
* Perform functional testing, troubleshoot issues, and ensure successful deployment.
* Support hypercare and post-go-live activities.

Documentation & Compliance
* Maintain comprehensive documentation, including URS, FRS, and SOPs.
* Ensure adherence to GMP, 21 CFR Part 11, and data integrity standards.

Training & Support
* Provide end-user training and knowledge transfer.
* Act as a subject matter expert for MES processes and best practices.

Qualifications:
* Bachelor's degree in Engineering, Computer Science, Information Technology, or related field.
* Advanced english level.
* 3-5 years of hands-on experience with MES systems (e.g., Syncade, PharmaSuite, PAS-X)
* Strong understanding of manufacturing processes and regulatory requirements (GMP, FDA).
* Familiarity with ERP integration (SAP preferred) and automation systems.
* Knowledge of IT lifecycle management and validation processes.
* Soft Skills: Strong analytical and problem-solving abilities. Excellent communication and stakeholder management skills. Ability to work in a global, cross-functional team environment.

Nice-to-Have
* Certifications in GAMP5, ITIL, or Project Management.
* Exposure to cloud-based MES solutions and digital manufacturing initiatives.

#LI-LATAM

About AccentureAccenture is a leading global professional services company that helps the world's leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services-creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world's leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.
Visit us at www.accenture.com

Equal Employment Opportunity Statement

We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, military veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by applicable law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities