Job Overview:
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We are seeking a skilled Commissioning and Qualification Lead to join our project team. The ideal candidate will have strong experience in managing teams, project and engineering management, as well as knowledge of FDA/EMA and cGMP regulations.
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Main Responsibilities:
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* Design the C&Q detailed approach for the project, based on the endorsed strategy.
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* Coordinate the Sanofi C&Q work with the EPCMCQ engineering contractor.
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* Ensure all C&Q documents are completed on time.
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* Author URS documents as per schedule.
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* Deliver C&Q activities and qualification report on time.
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* Manage deviation process and ensure deviations are closed on time.
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* Provide support to project change, engineering change and technical change assessment.
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* Prepare transition after OQ/PQ with MSAT and Operations.
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* Collaborate with the project team.
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About You:
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The successful candidate will have:
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* Strong experience of pharmaceutical facility start-up and commissioning.
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* Several years of professional experience in managing teams (direct and indirect) in the pharmaceutical industry.
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* Proven multi-year experience (>10 years) in the area of project and engineering management.
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* Good knowledge of FDA/EMA and other regulatory requirements such as cGMP.
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* Strong knowledge and experience in performing facility / equipment / utility commissioning and/or qualification, including automated and computerized system.
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* Knowledge of commissioning and qualification in active pharmaceutical ingredient production environment, greenfield/brownfield project and/or operational facility.
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* Very good communication and presentation skills.
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* Systematic and structured work style.
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* Fluency in German and English.
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* A PhD or Masters degree in engineering or natural science field.
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Benefits:
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At our organization, 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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Our Culture:
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We value diversity and inclusion and strive to create an inclusive work environment that allows everyone to thrive. We believe that by embracing differences and promoting inclusivity, we can achieve our mission and make a positive impact on people's lives.
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Join Our Team:
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If you are passionate about leading high-performing teams, driving project success, and making a difference in people's lives, please apply for this exciting opportunity!