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Building on experience, results and commitment.

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We’re EDV Werke, a Digital Quality & Advanced IT Solutions provider from scenic Switzerland.

As a trusted IT Partner to the world’s leading technology solutions, we act as digital transformation advocates for some of the world’s most beloved and widely used IT solutions.

We provide exceptional world-class IT solutions (in the words of our clients) across both consumer, and enterprise sectors by leveraging our experience, commitment, and extensive knowledge. Since the beginning, EDV Werke AG’s approach has been one of true partnership and we work in close collaboration with our clients.

Back at you – see new exciting opportunities below, and tell us more about yourself by applying. 

We’d love to hear from you!

 

For one of the strategic IT projects EDV Werke is looking for a CSV Specialist

Position descripiton:

  • Technologies: CSV, GMP, MES
  • Location: US, South Carolina, hybrid working mode
  • Area and form of employment: B2B Contract
  • Experience level: Senior

Your main tasks as the CSV Specialist will be:

  • Understanding the manufacturing procedure based on business people conversations
  • Acquire Pharma Suite and recipe design expertise built on IT SME teaching and coaching.
  • Being able to be independent for formula implementation and testing performance
  • Creating of SLDC validation documents:
    • Validation Plan
    • xQ Plan
    • xQ Report
    • Validation report
  • Reviewing and supporting the update of Functional Requirement Descriptions and Risk Calculation, OQ and PQ Validation procedures
  • Executing testing and/or OQ validation procedures
  • Evaluating executed validation protocol from a value perspective
  • Being active with Validation contact to get the validation deliverables from provider

To be successful in this role you should have:

  • 10 years of involvement in global pharma and biotech business and in CSV activities/ventures
  • Established practical involvement in the writing of validation deliverables like:
    • specifications
    • validation test scripts
  • Experienced in business case development
  • Knowledge of chemical and biological GMP manufacture:
    • drug substance,
    • drug product
    • excipients in an global set-up with exhibited ability to translate and apply related value and regulatory obligations.
  • Established managing practice in an EMA / FDA regulated environment, and an exceptional working expertise of existing ICH, PIC/S, EU and US regulatory needs and their application
  • Exceptional understanding of MS Office
  • Strong background of MES systems
  • Demonstrated capability to lead and encourage interdisciplinary groups
  • Solid organizational abilities, capability to balance various priorities at the same time
  • Self-starter and hands-on
  • Team-oriented, detail-oriented, efficient, and solution-oriented attitude
  • Superb analytical and problem-solving skills
  • Excellent communication and interpersonal skills
  • Flexibility and ability to work independently and in a team
  • Great English skills (written and spoken)

You can expect:

  • B2B Contract
  • Challenging job in an international and multilingual environment
  • Professional development
  • Attractive and competitive compensation
  • Professional support, possibility to gain new skills and training

 

If you are interested in this position, please apply by sending your CV in .doc or .pdf format for immediate consideration.

Thank you, EDV WERKE Team

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