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 the EU and can work remotely but needs to travel onsite 15% of the time.
Contract Duration: 12 months
Interview: 2 rounds
No of positions: 2
Responsibilities
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
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