Job Title: MES Architect

Location: Bridgewater, NJ(Hybrid)

Duration: Long Terms

Open Rate

Job Description

Client is looking 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.

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.

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.
• 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.