CSV Engineer Computer Systems Validation

agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma Biotechnology Medical Devices Energy Infrastructure Transportation Chemicals and Information Technology sectors.

As a consultant you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing whats behind closed doors of the biggest projects of our clients portfolio.

Tasks

The CSV engineer is in charge of ensuring the validated state of computerized systems on manufacturing site including laboratory equipment.

Create the requested CSV documents: risk analyses traceability matrixes validation protocols.

• Organize the review of the CSV documents by the QA teams.
• Execute the CSV test and support the CSV timelines.
• Write CSV reports.
• Work in close collaboration with the CSV and CQV lead Engineers.
• Interact closely with Process Engineers Automation Team (EMR) PM and QA.
• Ensure GAMP5 compliance follow the ASTM guidelines.

Requirements

• You hold an engineering diploma in Biotechnology Bioprocess or Chemical Engineering or similar.
• You have a Minimum of 3 years in Commissioning Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects.
• You have Expertise in automation and vertical integration as well as data management under validated computer systems.
• You know planning CQV activities leading large senior reports.
• You have a proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH PIC/S EU and US regulatory requirements and their implementation.
• You are fluent in English German highly beneficial.

Benefits

Joining a group with strong development potential that aims to improve your employability on challenging and varied projects

• Joining a structure that has been established in Switzerland for a long time with a client portfolio that includes leaders in the sector
• Having a sustainable job with stability and access to a real collaboration
• Benefit from training with accredited and certified centers
• Having a local management team to support you in the achievement of your missions and in the development of your career
• Being part of a dynamic committed team with real human values that we live by every day

Only applications from Swiss and EU citizens will be considered.