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C&Q Lead IFF (all genders)
Posted 4 hours 20 minutes ago by Sanofi EU
To ensure a rapid processing of your application, please apply only via the "Apply" button. Please include a letter of motivation and a current resume with your application.
About the job
Are you ready to jump into a mega project (> 1 B€ Capex program, thereof design/engineering budget
Your skills could be critical in helping us to achieve our key project milestones. You will lead all Commissioning and Qualification activities from Basic Engineering until end of Qualification activities in accordance with EHS, Quality, Engineering, Business & Users requirements standard and expectations. Within the IFF project team, and part of our InsuLINK program for insulin drug substance facilities.
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:
To lead the IFF C&Q team (system leaders, per workstream / group of systems)
To design C&Q detailed approach for IFF, based on endorsed strategy as per C&Q project plan, for all systems (GxP and non-GxP)
To coordinate the Sanofi C&Q work with the EPCMCQ engineering contractor for C&Q topic and all disciplines withing Sanofi IFF organization
To ensure all C&Q documents are on time with Sanofi / EPCMCQ contractor, including FAT/SAT documents
To author URS as per schedule
To deliver C&Q activities and qualification report on time
To lead and manage deviation process and ensure deviation are closed on time with all expected documents, with no impact on schedule L2
To provide support to project change, engineering change and technical change assessment with regards to C&Q part
To prepare transition after OQ/PQ with MSAT and Operations
To collaborate to project meeting
About you
Experience: Strong experience of pharmaceutical facility start-up and commissioning; Several years of professional experience in managing teams (direct and indirect) in the pharmaceutical industry; Proven multi-year experience (>10 years) in the area of project and engineering management; Experience in working in a large, complex matrixes environment with global processes and governance structures
Soft and technical skills: Good knowledge of FDA/EMA and other regulatory requirements such as cGMP; Strong knowledge and experience in performing facility / equipment / utility commissioning and/or qualification, including automated and computerized system; knowledge of commissioning and qualification in active pharmaceutical ingredient production environment, greenfield/brownfiled project and/or operational facility; Very good communication and presentation skills; Systematic and structured work style
Education: Phd.; Masters degree or diploma in engineering or natural science field
Languages: fluency in german and english
Pursue Progress . Discover Extraordinary .
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