
Pharmaceutical Manufacturing Systems Expert
1 day ago
Senior Pharmaceutical Software Specialist
A highly skilled and experienced Senior Pharmaceutical Software Specialist is required to design, develop and configure software systems for pharmaceutical manufacturing processes. The ideal candidate will have expertise in MES recipe design and deployment, as well as a strong understanding of SDLC and pharmaceutical regulations.
Key Responsibilities:
- Develop and implement MES recipes using Rockwell FTPS, ensuring compliance with industry best practices.
- Design and implement building blocks for reusable recipe structures.
- Collaborate closely with process engineers and manufacturing teams to map end-to-end pharmaceutical processes, focusing on biologics.
- Ensure compliance with pharmaceutical regulations (GMP, GxP, 21 CFR Part 11).
- Participate in the full MES lifecycle, from design and validation to deployment and support.
- Perform recipe testing, troubleshooting and validation in alignment with SDLC methodologies.
- Collaborate with DCS teams to ensure seamless integration between MES-DCS for automated manufacturing.
- Support and maintain MES systems in a validated state, ensuring high availability and performance.
Requirements:
- MES experience in life sciences manufacturing, specifically with Rockwell FTPS.
- Hands-on experience in MES-DCS integration for process automation.
- Knowledge of ERP and Data Historian integration with MES.
- Hands-on experience in recipe authoring, building block development and validation.
- Strong understanding of pharmaceutical manufacturing, especially biologics.
Preferred Skills:
- Excellent communication skills to collaborate with cross-functional teams.
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