Siemens Opcenter Developer

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting‑edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, Docu Sign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real‑time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

The Siemens Opcenter Developer will design, configure, and deploy MES solutions—primarily Siemens Opcenter (XFP) and Rockwell Pharma Suite—to support compliant manufacturing operations. The developer collaborates closely with manufacturing, quality, engineering, IT, and validation teams to gather requirements and translate them into functional and technical MES designs. Responsibilities include configuring master data, system parameters, and process instructions aligned with GMP‑regulated manufacturing workflows.

The role also involves developing and testing integrations between MES and enterprise systems such as JDE, Lab Ware, OSI PI, and plant automation platforms like Delta

V. Compliance with cGMP, FDA, ISPE, and GAMP 5 standards is maintained throughout configuration, development, testing, and troubleshooting activities.

• Design, configure, and deploy MES solutions (primarily Siemens Opcenter XFP and Rockwell Pharma Suite) to meet production and compliance requirements.
• Collaborate with cross‑functional teams, including but, not limited to Manufacturing SME’s, Process Engineering, MS, Quality Assurance, Quality Validation, IT, and the respective computerized system teams related to MES interfaces—to gather and analyze business and process requirements.
• Convert gathered business and process requirements into detailed technical specifications and functional designs.
• Ensure MES solutions are compliant with applicable industry regulations, including cGMP, FDA, ISPE, and GAMP 5 standards.
• Design, develop, and implement MES process instructions aligned with manufacturing workflows and business requirements.
• Set‑up system parameters, master data, and configuration settings.
• Implement and manage data synchronization processes to maintain consistency and accuracy across MES and other enterprise systems.
• Develop and support integration workflows between MES and enterprise systems such as JDE, Lab Ware, OSI PI, and plant automation equipment (e.g., DeltaV).
• Perform comprehensive integration testing to ensure seamless data exchange between MES and connected systems, resolving any issues discovered during testing.
• Analyze existing MES code and scripts to understand system logic and processes and troubleshoot as necessary.
• Contribute to the configuration, development, troubleshooting, and end‑to‑end testing of MES applications and system functionalities.

• Performs other related duties and assignments as required.

• System Integration
  
  Experience:
  
  JDE, OSIPI, Labware, and Delta
  
  V.
• MES Platform:
  Siemens Opcenter Execution Process (formerly known as SIMATIC IT Unified Architecture for Process Industries) a plus, CAMSTAR or any other MES System Database Platforms:
  Microsoft SQL, Oracle, etc.
• Project Documentation:
  Microsoft Office.
• Experience in MES Implementation, preferably Siemens Opcenter.
• Minimum 7+ years working experience in Pharmaceutical/biotech industries.
• Experience in FDA regulated industry and familiarity with CFR 21 Part 11, cGMP.
• Technical attitude: ability to learn new systems and information quickly.
• Demonstration…