Clinical Trial Supply Manager
Ascendis Pharma
Instrumentation and Controls Lead Engineer
Sanofi
full-time
Posted on:
Location Type: Office
Location: Frankfurt am Main • 🇩🇪 Germany
Visit company websiteJob Level
Senior
About the role
- Lead as the I&C subject matter expert for the Insulin Frankfurt facility project and report into an Automation Project Lead
- Execute instrumentation and control activities supporting automation deliverables for strategic capital projects
- Ensure project implementation aligns with customer orders on costs, deadlines, quality, and resources and initiate corrective actions for deviations
- Define automation requirements during detailed design and support preparation/review of I&C deliverables
- Lead troubleshooting, field walkdowns, installation, commissioning activities and resolve I&C issues during design, construction and site installation
- Review instrumentation specifications, participate in design reviews and provide technical guidance to I&C contractors and third-party vendors
- Lead and participate as I&C representative in FAT, SAT and Critical Test Plan execution
- Oversee quality of controls hardware and instrumentation installation during FAT and SAT to ensure compliance
- Lead updates to I&C design documentation during Commissioning and Qualification and ensure alignment with automation philosophy and strategy
Requirements
- Experience in applied instrumentation and controls and automation design engineering and project experience
- Experience in construction/installation, equipment start-up, qualification and/or validation (mandatory)
- Direct knowledge of Automation System design and process control engineering
- Experience troubleshooting GMP biopharmaceutical production facility equipment/systems automation (media, harvest, bioreactors) and integrating various OEM automation software
- Experience defining automation requirements and preparing/reviewing I&C deliverables (Instrument Lists, IO Lists, wiring diagrams, fieldbus segment diagrams, riser diagrams, control panel design drawings)
- Experience leading FAT, SAT, and Critical Test Plan execution
- Extensive understanding of programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies
- Strong leadership, technical writing, and communication/presentation skills
- Minimum B.Sc in Electrical, Automation Engineering or Computer Science or equivalent job certificate/education
- Proficiency in English required; German language skills a plus
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
instrumentation and controlsautomation design engineeringtroubleshootingGMP biopharmaceutical productionautomation system designprocess control engineeringfield instrumentation technologiesprogrammingdesign documentationlifecycle management
Soft skills
leadershiptechnical writingcommunication skillspresentation skills
Certifications
B.Sc in Electrical EngineeringB.Sc in Automation EngineeringB.Sc in Computer Science
