Philip Morris - Computerized System Validation Engineer

Randstad (Schweiz) AG — Neuchatel
23.01.2020 | Employee | 100%

Philip Morris - Computerized System Validation Engineer

Are you looking for your next challenge in a fast-paced and exciting multinational environment? In this case, you should take a look at this opportunity! We're looking for a :

Computerized System Validation Engineer ? Technical Services

Initiale duration : one year

Start date : ASAP

Be a part of a revolutionary change

At PMI, we've chosen to do something incredible. We're totally transforming our business and building our future on smoke-free products with the power to improve the lives of a billion smokers worldwide.

With huge change, comes huge opportunity. So, wherever you join us, you'll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.

It's so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that's exactly what's happening. R&D is the driving force for our bold new vision to replace cigarettes with a revolutionary portfolio of alternative products.

Join us and you'll have the resources, support and technology you need to break new ground and see ideas come to life. You'll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers.

If you're creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free future, your work could change the lives of a billion smokers.

Responsabilities :

  • Provide support and expertise on Computer System Validation activities according to PMI procedures and policies as well as legal requirements (FDA)
  • Run CSV projects execution ensuring timelines are met
  • Prepare, review and manage the workflow of all GxP system life cycle deliverables (VP, URS, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report
  • Plan, prepare and execute all activities of commissioning related to the CSV in close collaboration with external suppliers
  • Establish a good and efficient channel of communication with the different members of the project team IT, operation, QA and technical services
  • Manage all unexpected changes through deviation, change control, NC and CAPAs following PMI QMS.

Skills and Competencies :

  • Education: Master's degree or Bachelor in Computer Science, Life Sciences, Engineering, Biotechnology, Physics, Chemistry, Automation or equivalent
  • Work experience: 3 years proven track record in Computer System Validation in Pharmaceutical or Life Science environment.
Other skills:
  • Strong understanding of control systems (PLC, SCADA, HMI)
  • Strong understanding of IT environment (Server, network, database)
  • Strong project management skills with the ability to prioritize assignments
  • Familiar with GxP systems
  • Fluent knowledge of GAMP 5, CFR Part 11 and data integrity concept
  • Languages: English fluent and French is a plus
  • Excellent analytical and problem-solving skills.

23.01.2020
Employee, 100%

Contact

Randstad (Schweiz) AG


Randstad (Schweiz) AG

Leutschenbachstrasse 45Zurich
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