Validation CSV Pharma [F/M/X]
Job description
Mission / Role Overview
As a Computer Systems Validation (CSV) Engineer, you will support the validation of cGMP‑critical computerized systems and software packages within a pharmaceutical/GMP environment. You will contribute to the full validation lifecycle (URS to PQ), ensuring systems remain in a validated state and compliant with cGMP, cGLP, FDA and EU regulations, as well as internal procedures.
Key Responsibilities
URS, SIA, DQ, IQ, OQ, PQ, RV and TM
Validation studies for cGMP‑critical computerized systems to demonstrate compliance with cGMP, user and regulatory requirements
Develop, implement and execute validation activities and documentation, including:
Prepare and maintain validation documentation (protocols, reports, test scripts) and support/perform protocol execution for computerized systems.
Own validation documentation through review, approval and implementation.
Perform validation of systems where industry precedence exists but standards must be interpreted and adapted to the specific case, in line with cGMP, cGLP and internal procedures.
Ensure the validated status of computerized systems is maintained and compliant with cGMP at all times.
Contribute to project execution in accordance with all applicable company and cGMP regulatory standards.
Stay current on emerging validation regulations, guidelines and testing practices to meet or exceed cGMP requirements.
Provide technical input on current US FDA and EU validation requirements.
Participate in change assessments to determine impact on validated status and validation documentation.
Investigate and troubleshoot validation issues and deviations, proposing and implementing corrective actions.
Profile \& Requirements
Experience
1–3 years of experience in Computer Systems Validation or related QA/Validation roles.
Minimum 3 years’ experience in a pharmaceutical sector and GMP environment (project, internship or combined roles can be considered if strongly relevant).
Project experience with validation of software packages and computerized systems.
Technical Skills
Solid understanding of Computer Systems Validation principles and lifecycle.
Good knowledge of cGMP, cGLP and relevant quality/compliance regulations (e.g. 21 CFR Part 11, Annex 11\).
Ability to develop and execute validation protocols and reports.
Capable of troubleshooting validation and system issues.
Experience with DCS systems (e.g. Emerson DeltaV) is a strong advantage.
Soft Skills
Strong communication skills (written and verbal) in English and Dutch.
Able to work independently, with a proactive and fast‑learning mindset.
Structured, detail‑oriented and able to execute activities according to plan and deadlines.
Team player, able to collaborate with QA, IT, Engineering and Business stakeholders.
Why joining us?
Rapid growth Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.
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.
Who are we?
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 for over a decade – this is made possible by an international team of 7,600 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. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
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 line 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: 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 you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
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