MES Architect

We are seeking an experienced MES (Manufacturing Execution System) Architect with expertise in Tulip to design, implement, and manage our MES solutions within a biotech environment. This role will be responsible for leading the architecture and deployment of Tulip s platform across manufacturing operations, ensuring seamless integration with existing systems while meeting the specific regulatory and operational needs of a biotech company. The MES Architect will work closely with cross-functional teams such as production, quality, IT, and compliance to ensure that the digital manufacturing strategy aligns with business goals and regulatory requirements.

Key Responsibilities:

• Architecture & Design:

o Lead the architectural design and roadmap of the Tulip MES platform in alignment with the company's manufacturing digital transformation strategy.

o Define system requirements and develop scalable solutions that meet the specific needs of the biotech manufacturing environment, including GMP compliance.

o Establish data models, workflows, and user interfaces that support efficient and compliant manufacturing processes.

• Implementation & Integration:

o Oversee the deployment of Tulip s MES solutions across multiple production sites, ensuring smooth integration with existing ERP, LIMS, and other enterprise systems.

o Collaborate with production teams to design workflows, digital work instructions, and dashboards tailored to the manufacturing process.

o Ensure data flow integrity between MES and critical systems (e.g., PLC, SCADA, historians).

• Customization & Optimization:

o Customize the Tulip platform to meet specific production and operational needs, incorporating features such as digital twins, IoT integrations, and realtime data analytics.

o Continuously optimize the platform s performance, user experience, and scalability.

• Regulatory Compliance:

o Ensure that the MES platform adheres to biotech/pharma regulatory standards, including FDA 21 CFR Part 11 and GMP requirements.

o Develop and implement validation protocols, change control processes, and ensure audit-readiness of the system.

Collaboration & Communication:

o Act as a liaison between IT, production, and quality teams to gather requirements and provide MES-related solutions.

o Provide guidance and mentorship to junior team members and system users, developing training materials and conducting workshops.

• Innovation & Strategy:

o Stay current with emerging MES technologies and industry trends to introduce innovative solutions.

o Provide strategic input to management regarding MES investments, upgrades, and lifecycle management.

Required Qualifications:

• Educational Background: Bachelor's or Master's degree in Computer Science, Information Systems, Engineering, or a related field.
• Strong understanding of the biotech/pharma manufacturing environment is required.
• 7+ years of experience in MES architecture, with specific expertise in Tulip.
• Experience working in biotech, pharmaceuticals, or related regulated environments, with a focus on GMP compliance and digital manufacturing.
• Proven track record of designing and deploying MES solutions in a multi-site, regulated environment.
• Experience in integrating MES systems (Tulip) with ERP system S4 Hana.

Technical Skills:

• Deep understanding of Tulip s MES platform and experience in configuring workflows, dashboards, and IoT integrations.
• Knowledge of related systems such as SAP, LIMS, SCADA, and process automation technologies.
• Proficiency in programming/scripting languages for system customization (e.g., Python, JavaScript).
• Familiarity with cloud infrastructure, middleware technologies and data management strategies.

Regulatory Knowledge:

• Experience with GMP, FDA 21 CFR Part 11, and other industry regulations.
• Familiarity with validation processes and requirements for software in regulated industries.

Soft Skills:

• Excellent problem-solving skills, with the ability to think strategically and operationally.
• Strong leadership and communication skills, with the ability to work across diverse teams.
• Ability to manage multiple projects and stakeholders in a fast-paced environment.

Preferred Qualifications:

• Experience with biotech manufacturing processes (cell therapy, biologics, etc.).
• Knowledge of other MES platforms and digital manufacturing trends.
• Previous experience leading digital transformation initiatives in a regulated environment