CSV Engineer

Bachem | 20.11.2017


CSV EngineerPrintSchweiz, Bubendorf
Job-ID: 13693041

Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe and the US, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

Bachem. Pioneering Partner for Peptides

    Your Responsibilities
    The CSV Engineer position is a full time role reporting to the CSV Manager, Global IT

    Your Tasks
  • Contribution in the development and execution of a global CSV strategy with a focus on complex computer systems
  • Ensure compliance of relevant computer systems and applications with regulatory requirements and controls associated with CFR 21 Part 11 and EU GMP Annex 11
  • Development and maintenance of life cycle documents necessary to address the CSV requirements within the system development lifecycle (Risk assessments, validation plan, SOP, etc.) according to the Global CSV Strategy
  • Work closely with local Q-Departments and other compliance involved personnel within other Bachem locations
  • Participate in IT Projects and manage all activities in regards to validation and qualification of computer systems and applications
  • Provide CSV education within Bachem
  • Provide CSV related responses to inspectors/auditors as required

    Your Profile
  • Fluent in German and English with a degree in a relevant subject (chemistry, life science, engineering, computer sciences) with minimum 7 years` experience
  • Proven track record in validation and qualification of complex computer systems, including experience with writing, reviewing and executing computer validation documentation (Validation plan, IQ, OQ, DQ, SOP)
  • Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP 5 standards
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently, manage one`s time and function in a team environment

    We offer
    You will be part of a motivated team overseeing the entire development cycle of APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.

Interested

Please submit your application with full supporting documents (motivation letter, CV, testimonials, diplomas) online to Frau Iris Hreinsdottir.Hauptstrasse 144, 4416 Bubendorf, Tel.: +41 58 595 2931



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