QA Qualification & Validation Enginner (F/M/X)

Amaris-Consulting; Geel; Hybrid; EUR 55,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting is seeking a QA Qualification & Validation Engineer to support QA activities across qualification and validation lifecycles for pharmaceutical equipment, facilities and processes. You will ensure cGMP compliance and collaborate with cross-functional teams to maintain a compliant GMP environment.

Requirements include proven QA qualification/validation experience in a regulated setting, strong cGMP knowledge, and familiarity with QA documentation and risk management.

Qualifications

• Experience in QA qualification and validation within a pharmaceutical or regulated industry.
• Strong knowledge of cGMP requirements and relevant pharmaceutical guidelines.
• Experience reviewing qualification and validation protocols, reports and quality documentation.
• Understanding of risk assessments, deviation management, change controls and CAPAs.
• Ability to prioritize activities and communicate decisions clearly.
• Familiarity with TrackWise, Kneat or similar systems is an advantage.

Responsibilities

• Review and approve qualification and validation documentation, including URS, risk assessments, protocols, test plans, test scripts and final reports.
• Provide QA oversight and guidance for qualification and validation of equipment, facilities, utilities and processes.
• Ensure qualification and validation activities comply with cGMP and regulations.
• Review and follow up on deviations, change controls and CAPAs.
• Assess quality risks and ensure appropriate actions are implemented and documented.
• Support project teams throughout equipment and system lifecycle.

Skills

QA/QV experience

cGMP knowledge

Documentation review

Risk assessment

Cross-functional teamwork

TrackWise or Kneat

Tools

TrackWise

Kneat

Job description

QA Qualification & Validation Enginner (F/M/X)

Permanent Job

Are you experienced in Quality Assurance, qualification and validation within the pharmaceutical industry? Join our network of professionals and contribute to ensuring the quality, compliance and reliability of pharmaceutical equipment, systems and processes.

As a QA Qualification & Validation Engineer, you will support quality assurance activities throughout the qualification and validation lifecycle, ensuring compliance with cGMP requirements, applicable regulations and internal quality standards.

Your missions

Review and approve qualification and validation documentation, including User Requirements Specifications (URS), risk assessments, protocols, test plans, test scripts and final reports.

Provide QA oversight and guidance for the qualification and validation of pharmaceutical equipment, facilities, utilities and processes.

Ensure that qualification and validation activities comply with cGMP requirements, applicable regulations and internal quality standards.

Review and follow up on deviations, change controls and CAPAs related to qualification and validation activities.

Assess quality risks and ensure that appropriate actions are implemented and documented.

Support project teams throughout the equipment and system lifecycle, from project design and implementation to routine operations.

Collaborate with QA, engineering, operations, IT and other cross-functional teams to maintain a compliant GMP environment.

Your Profile

Experience in QA qualification and validation within a pharmaceutical or other regulated industry.

Strong knowledge of cGMP requirements and relevant pharmaceutical guidelines.

Experience reviewing qualification and validation protocols, reports and associated quality documentation.

Understanding of risk assessments, deviation management, change controls and CAPAs.

Ability to assess quality risks, prioritise activities and communicate decisions clearly.

Able to manage multiple priorities and work effectively with cross-functional teams.

Familiarity with quality management or validation platforms such as TrackWise, Kneat or similar systems is an advantage.

Fluency in Dutch and English is required.

What we offer

Joining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression.

In practical terms, here’s what this means for you on a daily basis:

Projects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the breadth.

Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts.

A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged.

Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact.

CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together.

Health insurance, remote work, meal vouchers, time savings account, referral bonus… We’ll talk about our full benefits package during our interviews.

Mantu 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!