CSV Engineer

EFOR; Oberwallis; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

EFOR Group in Visp, Switzerland, is seeking a CSV Engineer for an on-site role to support eQMS validation from a CSV perspective. The role emphasizes adherence to CFR Part 11, GAMP5, and Data Integrity, with responsibilities across validation planning, execution, and documentation within a TrackWise-based environment.

Applicants should have at least 5 years of CSV experience in multidisciplinary teams, a proactive approach, and strong teamwork.

Qualifikationen

• Expert in CSV and computer system validation.
• Good understanding of GAMP5 and CFR Part 11 requirements.
• Demonstrated knowledge of TrackWise Spring25 or above – QMS Module.
• At least 5 years’ experience leveraging CSV documentation in multidisciplinary project teams.
• Strong team-oriented mindset and organized working style.
• Agile, proactive problem-solving approach.

Aufgaben

• Coordinating the validation activities for the eQMS Project.
• Acting as contact person for CSV/DI questions within the project team.
• Defining the CSV/DI strategy for the eQMS Project.
• Producing validation documents (Validation Plan, FS, DS, FRA, URS, CS, IQ, OQ, PQ etc.).
• Ensuring compliance with GMP standards and internal SOPs on CSV and Data Integrity.
• Applying risk-based validation approaches.
• Editing and reviewing change requests, CAPAs and deviations related to CSV/DI.
• Contributing to CSV/DI guidance to influence strategy.
• Producing all necessary documents to support validation strategy design and execution.

Kenntnisse

CSV expertise

GAMP5 knowledge

CFR Part 11 knowledge

TrackWise experience

Team player

Agile

Tools

TrackWise Spring25

Jobbeschreibung

In 13 years, the EFOR Group has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions.

Our ambition is to build a global leading position of our market in 2028.

Today, we are an innovative organization working with passionate specialists and committed consultants according to our three values: Commitment, Excellence and Sharing.

In Switzerland, we work with 300 experts who support our customers on their various projects in the French- and German-speaking parts. We help our customers to diversify and to grow through the work of our consultants and the technical expertise of our Solution & Project Delivery Department.

To strengthen our team in Visp we are looking for a CSV Engineer

The Role:

You will be supporting eQMS Project, from a CSV perspective.

You are responsible for ensuring that the regulations regarding Computer System Validation and Data Integrity are implemented and rolled out according to applicable regulations (CFR 21 part 11, GAMP5) and internal standards for a Trackwise eQMS Project.

You also support the project team with answers regarding data integrity and the validation of computerized systems.

Your Responsibilities:

• Coordinating the validation activities for eQMS Project
• Contact person for all project team members regarding questions about CSV and Data Integration (DI)
• Definition of the strategy of CSV/DI process for the eQMS Project
• Produce the supporting validation documents (including but not limited to Validation plan, FS, DS, FRA, URS, CS, IQ, OQ and PQ test script protocols, AfiU, VSR) to the eQMS Project
• Ensuring that the eQMS Project remains in compliance with quality and regulatory requirements according to the applicable standards (GMP) and internal SOPs regarding Computer System Validation and Data Integrity and that processes are carried out in a timely manner
• Ensure Risk-based validation approaches are applied
• Edit and review change requests, CAPAs and deviations with regards to CSV and DI related to eQMS Project
• Define/contribute to CSV&DI guidance influencing strategy
• Ensure compliance within the eQMS Project
• Produce all necessary documents to support validation strategy design and execution

Your Qualifications & Experience:

• Expert in CSV
• Good understanding of GAMP5 and CFR Part 11 requirements
• Demonstrated Knowledge of Trackwise Spring25 or above – QMS Module
• At least 5 year’s experience in leveraging CSV documentation and insights in multidisciplinary project teams
• Strong team-oriented mindset
• Structured, focused, and well-organized working style
• Open-minded and receptive to new ideas and suggestions
• Agile, highly motivated, and driven
• Solution-oriented with a proactive approach to problem-solving

This is an on-site role.

Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.

Do you want to join a dynamic and ambitious company? EFOR is made for you.