Calibration Lead Insulin Facility Frankfurt (all genders)

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About the job:

Background

Are you ready to jump into a mega project (> 2 B€ Capex program, thereof design/engineering budget 200 m€) to bring in your experience & knowledge? The race is on to design & build our new Insulin flex facilities addressing BLA (Biologics License Application) inside a program of 2 news facilities in Frankfurt am Main, Germany and China.

You will lead all Calibration Process implementation activities from Basic Engineering down to Detailed Design for Program in accordance with EHS, Quality, Business & Users requirements focus on design to cost solutions & process replication for Glargine in China.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams.

With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main responsibilities:

• Collaborate to URS definition for calibration needs and ensure process parameter data are available (set point, ranges, resolution, tolerance) during design phases.
• Ensure link with legacy plant Calibration SME to advise on decision making and collect feedback for best integration.
• Design calibration strategy: Define registration process according to Sanofi Global standards (criticality assessment, maximum permissible error calculations)
• Define execution process including labelling, certificates management, compliance status.
• Lead "blue reviews" based on P&ID and instrumentation documentation with process, MSAT, manufacturing and quality teams to validate compliance parameters.
• Build and deliver calibration plan with measuring chains inventory, compliance parameters and adapted control frequencies for instruments, laboratory equipment and technical check activities (Environmental control in HVAC systems, thermal mapping)
• Ensure implementation of stand-alone calibration software tool. for C&Q phase (initial calibration registration) and its migration to iShift program for routine (periodic calibration) mode with support of CMMS key-user.
• Provide support to transfer calibration plans to to local maintenance and calibration teams (Germany and China) in order they prepare and manage execution plan for initial controls with local resources.

About you

• Experience: 5+ years in technical positions in industrial sites, including at least one experience in Validation or Calibration manager; Experience and knowledge of GMP, FDA, and EU guidelines and legal metrology guidelines; Experience in working in a large, complex matrixes environment with global processes and governance structures
• Soft and technical skills: Good general technical knowledge, ability to interact with experts, especially instrumentation; Act for innovation, initiating new and improved ways of working; Rigorous, organized, factual and results-oriented
• Education: Master's degree in industrial engineering domain: Process / Quality / Instrumentation, Generalist Engineer diploma
• Languages: fluency in english (Project language), German is a plus

Why choose us?

• Play an instrumental part in creating best practice within our manufacturing facility.
• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact Pursue Progress. Discover Extraordinary

Pursue Progress . Discover Extraordinary .

Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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