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Job Title: SAP MES Project Manager/Program Manager
Location: La Verne, CA
Duration:6+ Months
Job Description -
We are seeking an experienced SAP-MES Project Manager/Program Manager with a strong background in the pharmaceutical industry to lead and manage the design, implementation, and optimization of SAP and MES systems. The ideal candidate will have expertise in integrating SAP with Manufacturing Execution Systems (MES) and a deep understanding of pharmaceutical manufacturing processes, regulatory requirements, and industry best practices.
Key Responsibilities:
- Manage end-to-end implementation of SAP-MES solutions, ensuring alignment with organizational objectives and regulatory compliance.
- Define project scope, goals, deliverables, timelines, and budgets in collaboration with stakeholders.
- Oversee program execution, ensuring adherence to project plans and timelines.
- Lead the integration of MES platforms (such as Werum PAS-X, Siemens Opcenter, or Rockwell Pharma Suite) with SAP modules like SAP PP-PI, QM, and MM.
- Ensure seamless data flow and interoperability between SAP and MES for production planning, execution, and quality control.
- Partner with cross-functional teams, including IT, engineering, quality, supply chain, and production teams, to gather requirements and deliver tailored solutions.
- Communicate project status, risks, and resolutions effectively to all stakeholders, including senior management.
- Ensure that all SAP-MES implementations adhere to GxP, 21 CFR Part 11, and other pharmaceutical regulatory requirements.
- Lead efforts in Computer System Validation (CSV) for SAP-MES integration projects.
- Analyze and optimize manufacturing processes using SAP and MES data to improve efficiency, quality, and cost-effectiveness.
- Develop KPIs and dashboards to monitor system performance and manufacturing outcomes.
- Develop and implement change management strategies to facilitate smooth adoption of SAP-MES solutions.
- Train end-users and provide ongoing support to ensure effective use of the systems.
Education and Experience:
- Bachelor's degree in engineering, Computer Science, or a related field; advanced degree preferred.
- 8+ years of experience in SAP-MES project management, with at least 3 years in the pharmaceutical or life sciences industry.
- Proven track record of successful SAP-MES implementations in GxP-regulated environments.
- Strong knowledge of SAP modules (PP-PI, QM, MM, etc.) and MES platforms (e.g., Werum PAS-X, Siemens Opcenter).
- Familiarity with system integration tools and middleware (e.g., SAP MII, OPC servers).
- Understanding of pharmaceutical manufacturing processes, such as batch management, serialization, and electronic batch records (EBR).
- Project management certification (e.g., PMP, PRINCE2) preferred.
- Experience managing large-scale, multi-site SAP-MES projects.
- Proficiency in Agile, Waterfall, or hybrid project methodologies.
- Deep understanding of pharmaceutical regulatory standards (GMP, GAMP, 21 CFR Part 11).
- Expertise in Computer System Validation (CSV) processes.
- Strong leadership, organizational, and problem-solving skills.
- Excellent communication and interpersonal abilities to work with diverse teams.