CSV Consultant

Who we are

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe we have been rolling out solutions in major projects since 2007 – this is made possible by an international team of 7600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential.

At Amaris we strive to provide our candidates with the best possible recruitment experience.

We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call : Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews you will meet people from our team: your manager of course but also other people related to your future role. We will talk in depth about you, your experience and skills but also about the position and what will be expected of you. Of course, you will also get to know Amaris Consulting: our culture, our roots, our teams and your career opportunities!

Case study : Depending on the position we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario etc.

As every role is different we adapt the process accordingly always focusing on the best possible candidate experience. We look forward to meeting you!

Job description

Join our team and start a new adventure in an international and dynamic environment where you will be able to fulfil your career expectations in a fast-growing organization.

Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in an industrial field but above all being an ambassador of our organization to clients thanks to:

• Your interpersonal skills and ability to listen in order to build a strong relationship of trust with our clients and fully understand their challenges and issues.
• Your curiosity and eagerness to learn as we support over 1000 clients from all sectors worldwide.

Your missions

• Manage and implement Computer System Validation (CSV) activities according to GMP, GAMP 5, and FDA 21 CFR Part 11 regulations.
• Execute qualification and validation of laboratory instruments ensuring compliance with current regulations.
• Draft and review validation documentation including URS, IQ, OQ, and PQ.
• Collaborate with Quality and IT teams to ensure regulatory compliance.
• Conduct validation testing and support both internal and external audits.
• Provide technical support and training to clients on validation processes.
• Identify and implement best practices for optimization of validation procedures.

Your profile

• Experience with Computer System Validation (CSV) in pharmaceutical or biotechnology environments (minimum 2 years).
• Knowledge of GMP, GAMP 5, and FDA 21 CFR Part 11.
• Experience with qualification of laboratory instruments.
• Experience with drafting and reviewing validation documentation (URS, IQ, OQ, PQ).
• Knowledge of laboratory software systems.
• Academic background: Biomedical Engineering or a related field.
• Fluent Italian and English.
• Strong analytical and problem-solving skills.
• You have the ability to adapt to a dynamic and evolving environment and to collaborate effectively with diverse stakeholders.

What we offer

• An international community bringing together 110+ different nationalities.
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities.
• A robust training system with our internal Academy and 250+ available modules.
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.).
• Strong commitments to CSR notably through participation in our WeCare Together program.

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.