Description
Siemens EBR (XFP) Senior Specialist
Role Overview:
We are seeking a senior, experienced, professional familiar with Siemens Electronic Batch Record (XFP) systems to join our team.
The candidate will play a critical role in gathering requirements, translate in design specifications, managing and executing change controls, ensuring alignment with operational and compliance needs.
The candidate is also key part of the MES team to collaborate on standardizing the design of the Legacy Siemens version looking for the future version upgrade.
Key Responsibilities:
- Execute and manage change control processes within Siemens EBR (eBatch).
- Collaborate with cross-functional teams to ensure changes meet operational requirements.
- Understand and analyze site-specific needs to effectively implement solutions.
- Ensure compliance with regulatory standards and site procedures.
- Provide technical support and guidance for Siemens eBatch-related issues.
- Document changes, troubleshooting steps, and outcomes thoroughly.
- Engage proactively with stakeholders to identify opportunities for process improvement.
Required Skills & Experience:
- Proven hands-on experience with Siemens EBR (eBatch).
- Experience executing change control procedures in regulated environments.
- Strong understanding of manufacturing processes, particularly in pharmaceutical, biotech, or related industries.
- Excellent analytical and problem-solving skills.
- Ability to communicate effectively with team members and stakeholders.
- Detail-oriented with a commitment to quality and compliance.
Desirable Skills:
- Familiarity or basic proficiency with SQL databases would be advantageous.
- Experience in environments governed by GMP standards.