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CSV Engineer

Bachem AG

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CSV Engineer

Bachem. Pioneering Partner for Peptides

- 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