Lead deployment, configuration, and validation of Siemens OpCenter Execution Pharma (EBR) and OpCenter APS (Scheduling) within GMP-regulated environments.
Design and implement MES integrations with ERP, LIMS, and automation systems to ensure seamless data flow and compliance with 21 CFR Part 11, Annex 11, and FDA/MHRA Data Integrity guidelines.
Administer and optimize Oracle/SQL databases supporting MES operations; develop ETL processes and Power BI dashboards for real-time production insights.
Collaborate with cross-functional teams (IT, QA, Manufacturing, Engineering) to drive system improvements, user training, and change management.
Conduct risk assessments per GAMP 5, author validation documentation (IQ/OQ/PQ), and support regulatory audits.
Job Qualifications:
Required: Bachelor’s degree in Computer Science, Information Technology, or Business Administration.
Required: 5–8 years of enterprise systems experience; MES solution deployment in Pharmaceutical, Biotechnology, or Life Sciences preferred.
Preferred: Hands-on expertise with Siemens OpCenter Execution Pharma (EBR) and OpCenter APS (Scheduling).
Preferred: Database administration (Oracle, SQL); proficiency in Power BI, ETL tools, and data modeling.
Preferred: In-depth knowledge of GMP, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles.
