Siemens Opcenter Executive

I am looking for Siemens Opcenter Execution Pharma Process Instructions (PIs) or POMSNet MES.

Please enable profiles for the below JD.

Start Date: 16-Mar-26

Country: Germany, Italy, Ireland : Candidate should be based anywhere in EU and can work remotely but needs to travel onsite 15% in a month. 

Contract Duration: 12 months

Interview : 2 rounds

No of positions: 2

• System Development and Configuration: Designing, configuring, and testing Siemens Opcenter Execution Pharma Process Instructions (PIs) to align with site-specific manufacturing requirements.
  
• Electronic Batch Record (eBR) Creation: Developing and implementing eBRs to replace paper-based systems, enhancing compliance and reducing review times.
  
• Regulatory Compliance (GxP/GMP): Ensuring all MES configurations adhere to strict regulatory standards, including Good Manufacturing Practices (GMP) and 21 CFR Part 11.
  
• System Integration: Integrating Opcenter with enterprise systems such as SAP (ERP), LIMS, and SCADA/control systems using SQL and web services.
  
• Validation and Documentation: Creating essential documentation, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and IQ/OQ/PQ test scripts.
  
• Process Optimization: Analyzing manufacturing processes to identify inefficiencies and implementing solutions to enhance productivity and traceability.
  
• Technical Support: Troubleshooting and providing support for Opcenter application issues, including managing user access and system performance.
  
• Training and Mentoring: Training key users on the system, creating user manuals, and providing guidance to junior engineers. 
  

Typical Qualifications & Skills:

• Experience range can be between 7 and 12+ years
  
• Experience with Siemens Opcenter Execution Pharma (Simatic IT eBR).
  
• Proficiency in SQL, databases, and system integration technologies.
  
• Background in pharmaceutical manufacturing processes (cGMP) and ISA-95/ISA-88 standards.