MES Architect

MES Architect

Job Description:

This is a long term consulting opportunity with our direct client in Bridgewater, NJ for a MES Manufacturing Execution System Architect who has a strong understanding of the Biotech / Pharma manufacturing environment.

The ideal candidate will have expertise in Tulip MES, but experience with Syncade or PAS X will also be acceptable.

This will be hybrid role - the consultant will be required to be on-site at the client location 3-4 days a week.

This person will design, implement, and manage the 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:

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

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

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

Implementation & Integration:

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

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

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

Customization & Optimization:

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

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

Regulatory Compliance:

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

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

Collaboration & Communication:

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

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

Innovation & Strategy:

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

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.

A strong understanding of the biotech/pharma manufacturing environment is required.

Experience:

7 years of experience in MES architecture, with specific expertise in Tulip, Syncade or PAS X.

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 with ERP system S4 Hana.

Technical Skills:

Deep understanding of 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.