QA Qualification & Validation Engineer [F/M/X] - #50107

Job Description

Are you experienced in equipment, system and process qualification/validation within the pharmaceutical industry? Do you want to play a crucial role in ensuring compliance, quality and reliability across the full lifecycle of facilities and systems? Then this role is an excellent match for you!

As a QA Qualification & Validation Engineer, you will support the QA Engineering department in ensuring that all qualification and validation activities meet regulatory and procedural requirements. You will be involved in lifecycle stages from concept and projects to operations and retirement.

Key Responsibilities

• Review and approve qualification/validation documents and quality records (SOPs, URS, risk assessments, test plans, test scripts, change controls, CAPAs…).
• Provide QA guidance in engineering teams introducing new or upgraded systems and processes, ensuring cGMP compliance.
• Follow up on deviations occurring during qualification/validation execution.
• Ensure compliance with regulations, guidelines, and internal standards.
• Communicate quality, compliance and planning status to QA teams.
• Collaborate with engineering, QA, operations, IT and automation teams.
  
  

Candidate Profile

• Experience in qualification/validation within chemical or pharmaceutical environments.
• Strong knowledge of cGMP regulations and industry guidelines.
• Ability to translate technical information into clear communication at all levels.
• Able to assess urgency, impact and criticality of QA decisions.
• Comfortable managing multiple projects simultaneously.
• Capable of working independently as well as in cross-functional teams.
• Familiar with systems such as TrackWise, COMET, TruVault, Kneat, or similar platforms.
• Fluent in Dutch and English.
  
  

Why join us?

• Fast growth: Amaris Consulting continues to expand rapidly in Belgium, offering strong development opportunities.
• High-impact missions: Work on critical qualification and validation activities in pharmaceutical environments.
• International culture: An agile, dynamic and multicultural environment promoting autonomy and intrapreneurship.
  
  

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. 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!