Senior Plant System Engineer

Role Overview

• 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.
• Business value realization: Drive adoption and business value realization of systems and data.

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.
• Commissioning/qualification/validation experience is 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.

Tech Stack

• SDLC

Benefits

• Health insurance
• 401(k) retirement plans
• Flexible working hours
• Professional development opportunities