Job detail for Process Plant and Commissioning and Qualification Specialist

A fixed-term contract based on objective grounds is possible for this position.

To ensure your application is processed quickly, please apply exclusively via the "Apply" button. Please attach a cover letter and a current CV to your application.

About the role

As C&Q Specialists within the transversal FBC Engineering Projects unit, we have a wide range of . Tasks range from technical and professional support during project planning to the qualification and optimization of rooms and equipment. Ready to get started?

About Sanofi:

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by turning "impossible" into "possible" for patients. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Key :

The purpose of this position is to provide technical and professional support for the project planning, commissioning, qualification, and optimization of equipment for the manufacturing, testing, and storage of pharmaceuticals/medical devices, including ventilation systems, cleanrooms, and laminar flow units.

• Development, further advancement, and implementation of a systematic and efficient commissioning and qualification concept with the goal of quality assurance, while adhering to company-specific requirements as well as national and international quality rules and standards.

• Establishing and maintaining the qualified state of facilities, equipment, and rooms within the scope of investment, repair, and improvement projects in collaboration with and cross-functional project teams as well as external service providers.

• Coordination/management and execution of risk analyses for technical equipment and rooms.

• Creation of commissioning and qualification documents.

• Support for Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).

• Coordination and execution of commissioning and qualification measures: design review, test phase (commissioning, IQ/OQ/PQ) of GxP-relevant equipment and rooms.

• Handling and assessment of changes to technical facilities and rooms throughout the lifecycle (Change Control / Change Request).

• Support in conducting / periodic reviews.

• Presentation of your own area of expertise during national and international authority inspections as well as internal audits.

• Business travel as part of project execution.

• Review and implementation of global and regulatory requirements into site-specific SOPs.

• Further development and optimization of the C&Q strategy for the aforementioned systems in coordination with teams (conceptual, templates, etc.).

• Collaboration in the creation and revision of global requirement documents.

About you

Experience:

• Completed degree in pharmacy, natural sciences, or engineering, preferably with a focus on process engineering / EMR / automation technology or pharmaceutical technology / medical technology, or a completed technical apprenticeship with several years of professional experience in the pharmaceutical industry.

• Several years of professional experience in the pharmaceutical industry.

Soft skills:

• Willingness to engage in transversal collaboration across functional boundaries / departments.

• Customer orientation.

• Team orientation / team player with excellent communication skills.

• Independent and systematic way of working.

• High willingness to communicate and ability to work in a team.

• Persuasive demeanor.

Technical skills

• Actively driving changes / optimizations in the area of responsibility.

• Result and solution orientation, willingness to take on responsibility.

• Knowledge of FDA and other regulatory requirements such as cGMP and DIN EN ISO 14644.

• Experience in conducting qualification and/or validation projects.

• Experience with authority inspections is an advantage.

Languages:

• Very good command of English, both written and spoken.

• Very good command of German, both written and spoken.

Why choose us?

• Discover the wonders of science with an innovative team to improve human health.

• An attractive, market-oriented compensation and benefits package, including company pension schemes, rewards your experience and contribution.

• We care for you and your family with a wide range of health and social benefits, such as high-quality healthcare, numerous prevention programs, free vaccinations, and coverage for long-term illness. A highlight is our 14-week paid family leave after the birth of a child for both parents, as well as various other support options for childcare and caring for relatives.

• To optimize your work-life balance, you benefit from flexible working time models and long-term accounts. Benefit from our hybrid work policy, use our fitness centers, or choose the option to participate in the bike leasing program. One day per year is available to you for voluntary social projects as part of our "We Volunteer" program.

• Start your career in Frankfurt and experience our modern working environments. For your commute, you are supported by an individually usable monthly mobility budget.

• Develop new skills, explore cross-functional roles, and work in an environment that values personal growth and a spirit of discovery.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

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

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

The salary range for this position is :€79 104,00 - €105 472

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.