Job description
About the Role
We are looking for a Commissioning & Qualification (C&Q) Engineer with 4–6 years of experience to support equipment and system qualification activities (FAT, SAT, IOQ) in a regulated pharmaceutical environment. You will ensure that tests are properly defined, executed and documented, in line with internal procedures, GxP expectations and leveraging strategies.
You will work closely with engineering, QA, production, automation and digitalization teams to secure compliant, efficient and on-time qualification of systems.
Key Responsibilities
FAT/SAT Documentation & Execution
Maintain and update FAT/SAT documentation and indexes, including the list of planned tests and leveraging opportunities.
Review and approve SAT protocols, ensuring that tests and requirements are aligned with qualification expectations and current SOPs (leveraging approach).
Prepare the SAT Go/No-Go checklist together with the responsible engineer and provide formal approval.
Follow the execution of SAT tests on site, support and guide testers, and verify in real time that tests are correctly documented and results are compliant.
Coordination & Stakeholder Management
Coordinate qualification activities with all relevant stakeholders (engineering, construction & maintenance, QA, production, automation, digitalization, etc.).
Escalate any blocking issues to the C&Q lead and provide regular updates on progress and status.
Drive the resolution of blocking points, ensuring timely follow-up and alignment between teams.
IOQ & Leveraging
Review and approve IOQ protocols, ensuring consistency with design, risk assessments and leveraging strategy.
Prepare the IOQ Go/No-Go checklist with the responsible engineer and approve it.
Supervise leveraging activities to optimize testing efforts while maintaining compliance.
Change Management, Risk & Traceability
Review changes and incidents with engineers and perform impact assessments on qualification and validation status.
Update the SRA (System/Software/ Safety Risk Assessment) process as needed based on changes, incidents or new information.
Draft and maintain the traceability matrix to ensure full coverage between requirements, risks, tests and results.
Profile (Experience & Background)
4–6 years of experience in Commissioning & Qualification, Validation or similar role in a GMP/GxP environment (pharma, biotech or related).
Solid understanding of FAT, SAT, IQ, OQ methodologies and leveraging concepts.
Experience working in cross-functional teams (engineering, QA, production, automation).
Strong documentation skills and attention to detail; comfortable reviewing and approving protocols and reports.
Ability to identify issues, drive problem resolution and communicate clearly with 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!
