Job Summary
We are looking for a skilled Siemens Opcenter Execution Pharma Engineer to join our team. The ideal candidate will have extensive experience with Siemens Opcenter Execution Pharma, formerly known as SIMATIC IT eBR, and a strong background in pharmaceutical manufacturing processes. This role involves developing, configuring, and maintaining the Opcenter Execution Pharma platform to optimize manufacturing operations, ensure regulatory compliance, and improve overall production efficiency. The Engineer will work closely with cross-functional teams to implement best practices and support continuous improvement initiatives.
Key Responsibilities:
Opcenter Execution Pharma Development and Configuration:
- Develop, configure, and maintain Siemens Opcenter Execution Pharma solutions.
- Customize Opcenter Execution Pharma workflows, data models, and user interfaces to meet business requirements.
- Ensure systems comply with pharmaceutical manufacturing regulations and standards.
System Integration:
- Integrate Opcenter Execution Pharma with other enterprise systems such as ERP, LIMS, and MES.
- Develop and maintain interfaces for seamless data exchange between Opcenter Execution Pharma and external systems.
- Ensure data integrity and consistency across integrated systems.
Process Optimization:
- Analyze manufacturing processes and identify opportunities for optimization and automation using Opcenter Execution Pharma.
- Implement best practices to enhance production efficiency and reduce operational costs.
- Develop and maintain standard operating procedures (SOPs) for system usage and maintenance.
Regulatory Compliance:
- Ensure Opcenter Execution Pharma solutions comply with regulatory requirements, such as FDA 21 CFR Part 11 and EU GMP Annex 11.
- Maintain documentation and validation records to support regulatory inspections and audits.
Project Collaboration:
- Collaborate with project managers, process engineers, and other stakeholders to gather requirements and develop technical solutions.
- Participate in project planning, timeline estimation, and resource allocation.
- Provide technical expertise and recommendations for Opcenter Execution Pharma-related projects.
System Maintenance and Support:
- Provide ongoing support and troubleshooting for Opcenter Execution Pharma applications.
- Monitor system performance and implement optimizations as necessary.
- Perform regular updates and maintenance to ensure systems remain current with the latest patches and features.
Training and Documentation:
- Develop and deliver training programs for end-users and technical staff on Opcenter Execution Pharma functionalities.
- Create and maintain technical documentation, including user guides, configuration manuals, and validation protocols.
Continuous Improvement:
- Stay updated with the latest developments in Siemens Opcenter Execution Pharma and related technologies.
- Identify and implement continuous improvement initiatives to enhance system performance and user satisfaction.
- Explore and recommend new features and enhancements to meet evolving business needs.
Qualifications and Skills:
- Bachelor’s degree in Engineering, Computer Science, Information Technology, or a related field.
- Proven experience with Siemens Opcenter Execution Pharma (SIMATIC IT eBR) in a pharmaceutical manufacturing environment.
- Strong understanding of pharmaceutical manufacturing processes and regulations.
- Proficiency in configuring and customizing Opcenter Execution Pharma solutions.
- Experience with system integration, including ERP, LIMS, and MES systems.
- Knowledge of database management and SQL for data manipulation and reporting.
- Strong problem-solving skills and attention to detail.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Familiarity with Agile methodologies and project management tools is a plus.
- Siemens Opcenter certifications or relevant training is highly desirable.
Preferred Skills:
- Experience with other Siemens Opcenter solutions, such as Opcenter APS or Opcenter RD&L.
- Knowledge of cloud-based deployment and management of Opcenter Execution Pharma.
- Understanding of industry standards and best practices for electronic batch recording (EBR) and manufacturing execution systems (MES).
- Experience with DevOps practices and tools for continuous integration and continuous deployment (CI/CD).
