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 crossfunctional 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:
- Bachelors or Masters 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 multisite 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 problemsolving 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 fastpaced 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.