IT - System Engineer designing tailored IT solutions while ensuring infrastructure security and performance. Join a dynamic team at wunderbar IT GmbH focusing on innovative technologies for B2B clients.
About the role
- Senior Plant System Engineer at Johnson & Johnson advancing data systems in pharmaceutical development. Collaborating with teams to optimize systems and ensure innovative solutions.
Responsibilities
- Design & Implement Software Solutions: Together with functional business leaders, data architects and IT, define future state plant systems landscape for the TDS pilot plants (MES, PI and Seeq), driven by business value
- Data Lifecycle Management: Have a solid understanding of the entire data process for the plant systems (systems (MES, PI and Seeq)) from collection to analysis, adhering to FAIR (Findable, Accessible, Interoperable, Reusable) data principles.
- Collaborate with Scientific Experts: Partner with scientists, engineers, and IT teams to optimize manufacturing systems, ensuring seamless data integration and usability.
- Stakeholder Alignment: Work closely with TDS stakeholders to align strategies, prioritize system enhancements, and promote widespread adoption of data solutions.
- Vendor Management: Manage relationships with vendors of laboratory, manufacturing, and data analytics systems to ensure quality, compliance, and innovation.
- Troubleshooting & Continuous Improvement: Identify and resolve system and data issues, proposing both immediate fixes and long-term improvements.
- Regulatory, Audit & SOP Management Support: Represent business user requirements during system upgrades, validations, and regulatory inspections to ensure compliance, data integrity, and operational excellence.
- Cross-Functional Leadership: Lead or contribute to projects across departments, fostering collaboration and innovation.
Requirements
- Bachelor’s degree or higher in Chemical Engineering, Chemistry, Pharma, Information Technology or related sciences/engineering disciplines is required.
- Minimum of 6+ years of relevant industry experience in pharmaceutical, biotech, or related sectors is required.
- Hands-on experience with MES (Körber PAS-X), Historian (AVEVA-PI), or Advanced analytics (SEEQ) in manufacturing environments is required.
- Experience with PLC-controlled equipment, process automation hardware and software, OT networks infrastructure and systems is highly preferred.
- Thorough knowledge of ISA S88/S95 standards is required.
- Proven experience with the drug development process, including tech transfer and product lifecycle management is preferred.
- Hands-on experience with advanced data analytics relevant to pharmaceutical development (at least two of the following areas): plant systems, process analytics, or digital tools is required.
- Demonstrated knowledge of Good Manufacturing Practice (GMP) regulations; proven understanding of GAMP and SDLC requirements is required.
- Experience with FAIR data principles and digital transformation projects is preferred.
- Organizational and project management skills, balancing multiple complex projects with effective customer management is preferred.
Benefits
- Inclusive work environment
- Professional development opportunities
Job title
Job type
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Not specified
Degree requirement
Tech skills
Location requirements
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