CSV Execution Engineer (6129)

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CSV Execution Engineer – 6129

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a CSV Execution Engineer to be based in Visp, Switzerland, with 100% onsite work.

This is an initial 12 months contract with possible extension already planned.

Responsibilities

• Acting as subject matter expert (SME) on following the CQV / CSV standards

• Participation within system classification assessments, to support the CSV SME. – Creation and execution of the requested CSV documents in accordance with SOPs and Guidelines while maintaining GDocP compliance.

• Participation in FAT & SAT testing.

• Creation and execution of validation protocols and associated reports as required.

• Maintain close collaboration with CSV Regional Leads or CQV Leads.

• Support of operational teams for technical changes or life cycle activities.

• Responsible for ensuring that Global Engineering projects are compliant in accordance with CQV/CSV guidelines, deliverables are aligned with local procedures and potential gaps are detected/resolved with an eye for continuous improvement.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required.

• Technical degree (bachelor level) in engineering or applied science, post graduate qualification preferred.

• Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable.

• Experience in regulated industries and/or engineering companies with proven experience in frontline (hands-on) tasks.

• Basic knowledge of ISPE GAMP5 and ASTM guidelines, awareness and/or desire to understand all applicable regulatory requirements prior to commencing GxP.

• Experience in automation and vertical integration process and ability to understand data flow.

• Familiarity with Data Integrity Principles, ALCOA+ concepts and ensuring compliance in GxP regulated Environments

• Strong analytical skills. Ability to conduct in-depth analysis of complex/large data sets, draw conclusions accordingly, and prepare and support decisions.

• Experience at working both independently and in a team-oriented environment

• Excellent command of English and proven knowledge in German necessary (read and write) and other desirable.