CSV Engineer

☞ Randstad Switzerland

View: 131

Update day: 18-03-2024

Location: Bern Bern BE

Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software

Industry: Staffing Recruiting Biotechnology Research Pharmaceutical Manufacturing

Position: Entry level

Job type: Full-time

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Job content

Do you want to work in a big pharmaceutical company? Do you have experience in CSV? You should then read the following lines!

Our client, based in the Bern area, is looking for a CSV Engineer for a 10 months contract.

Main Responsibilities
  • Support closing a CPA regarding audit trail review for QC equipment
  • Categorize all QC GxP systems according to global SOP and define the frequency of System Audit Trail review based on risk.
  • Perform a System Audit Trail review for those systems that require it based on their categorization.
  • Set up a maintenance task in SAP to plan subsequent reviews
Who we are looking for
  • Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experience
  • Several years of experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)
  • Good understanding of analytical technologies,
  • Strong analytical thinking and problem-solving ability
  • Excellent communication and teamwork skills
  • Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly
  • Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.
  • Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines.
  • Good verbal and written skills in English, German is a plus
Do not waste any minutes, apply now! We are looking forward to receiving your application.

Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
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Deadline: 02-05-2024

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