Role Summary:

We are seeking an experienced MES Solution Architect with expertise in Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X to lead MES transformation programs within Life Sciences organizations. The ideal candidate will have strong knowledge of pharmaceutical manufacturing processes, MES architecture, system integration, and regulatory compliance in GxP environments.

Key Responsibilities:

- Lead MES solution design and implementation using Siemens Opcenter Pharma and/or Werum PAS-X.

- Translate business and manufacturing requirements into scalable MES architectures.

- Design and configure solutions for Electronic Batch Records (EBR), Recipe Management, Weigh & Dispense, Genealogy, Traceability, and Production Execution.

- Integrate MES with ERP, LIMS, Automation/SCADA, Serialization, and Data Historians.

- Ensure compliance with GMP, GAMP5, FDA 21 CFR Part 11, and global regulatory requirements.

- Lead solution architecture, validation strategy, deployment, and go-live activities.

- Collaborate with Manufacturing, Quality, Validation, and IT teams to drive digital manufacturing initiatives.

- Provide technical leadership, governance, and mentoring to project teams.

Tech Stack & Requirements:

- 9 - 20 years of experience in MES, Manufacturing IT, or Digital Manufacturing.

- Hands-on experience with Siemens Opcenter Pharma (Camstar) and/or Werum PAS-X.

- Strong understanding of pharmaceutical and biotech manufacturing processes.

- Experience in MES integrations with ERP, LIMS, and shop-floor systems.

- Knowledge of ISA-95, Manufacturing Data Models, and Industry 4.0 concepts.

- Strong understanding of Computer System Validation (CSV) and regulatory compliance.

Preferred Qualifications:

- Bachelor's/Master's degree in Engineering, Life Sciences, or Information Technology.

- Experience working with global pharmaceutical or biotechnology companies.

- Knowledge of cloud, analytics, and smart manufacturing platforms.

- Strong stakeholder management, communication, and consulting skills.