MES Lead Engineer
Overview
We are seeking an experienced Senior MES Engineer to take ownership of PAS‑X configuration and serve as a key technical leader supporting site manufacturing operations. This role will guide the design, implementation, and optimization of MES solutions while ensuring seamless integration across automation, quality, and enterprise systems.
Key Responsibilities
MES Ownership & Configuration
- Serve as the primary owner of PAS‑X configuration activities, including batch record (MBR) development, materials setup, equipment and timer configurations, and label management.
- Lead the full lifecycle of MES enhancements-design, configuration, testing, deployment, and troubleshooting.
Systems Integration & Technical Leadership
- Act as the central technical liaison between MES and other key manufacturing systems such as DeltaV, ERP, LIMS, and additional shop‑floor applications.
- Provide expert support for the migration of MBRs from legacy systems to PAS‑X.
- Ensure all configuration and execution practices align with both site-level and global MES standards.
GMP & Compliance Support
- Contribute to risk assessments and maintain strong adherence to GMP and validation expectations.
- Deliver hands-on support during manufacturing execution, including issue investigation and real-time troubleshooting.
- Maintain accurate, up‑to‑date technical documentation for MES configurations and processes.
Cross-Functional Collaboration
- Work closely with Manufacturing, IT, Quality, and Engineering teams to drive alignment, resolve issues, and support ongoing operational readiness.
Required Qualifications
- 8+ years of experience in pharmaceutical or biopharmaceutical manufacturing.
- Strong, hands-on MES experience-PAS‑X preferred.
- Demonstrated expertise in MBR creation, configuration, and execution.
- Solid understanding of GMP manufacturing processes and regulatory expectations.
- Experience integrating MES with automation platforms like DeltaV, along with ERP and other enterprise systems.
- Strong analytical and problem‑solving abilities.
- Bachelor's degree in Engineering, Information Technology, Science, or a related field.
Preferred Skills
- Programming knowledge in .NET, SQL/PL‑SQL, or Java.
- Familiarity with OPC communication technologies.
- Understanding of 21 CFR Part 11 and EU Annex 11 requirements.
- Broad bioprocess understanding across upstream, downstream, and supporting manufacturing functions.
- Excellent communication skills, with the ability to partner effectively with both technical and non‑technical stakeholders.
FAQs
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