Asset Engineer – Commissioning & Qualification (F/M/X)

Amaris-Consulting; Oost-Vlaanderen; On-site; EUR 70,000 - 100,000; 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 dedicated Equipment Qualification professional to drive qualification activities in GMP environments within pharma/biotech sectors. You will manage documentation, coordinate testing and collaborate with QA and cross‑functional teams to ensure quality and regulatory compliance.

You will act as the technical owner for assigned systems, oversee IQ/OQ/PQ activities, and address deviations and investigations while maintaining lifecycle processes and continuous

Qualifications

• Degree in Engineering, Life Sciences, Biotechnology or a related technical field.
• Experience in equipment qualification and commissioning within pharma/biotech.
• Fluent in Dutch and English.

Responsibilities

• Coordinate equipment and utilities qualification activities to ensure compliance and timelines.
• Manage technical content of qualification documentation (URS, SRS, DQ, IQ, OQ, PQ).
• Act as technical owner for assigned systems and provide support for qualification questions.
• Assess projects, deviations, investigations and non‑compliance for impact on qualification.
• Review and approve qualification documentation and test records for accuracy and compliance.
• Collaborate with QA and cross‑functional teams to ensure documentation is reviewed and approved.
• Monitor progress, coordinate testing and ensure resources and materials are available.
• Manage deviations and quality issues using quality management systems.
• Maintain qualification processes and lifecycle activities.
• Contribute to continuous improvement and qualification training.

Skills

Equipment qualification

IQ/OQ/PQ

GMP knowledge

Documentation review

Cross-functional collaboration

Analytical thinking

Education

Engineering degree

Life Sciences/ Biotechnology background

Tools

TrackWise

Job description

Permanent Job

Join Amaris Consulting and contribute to challenging projects within the pharmaceutical and life sciences sectors. You will support qualification activities, ensuring that equipment and utilities meet quality standards and regulatory requirements in a GMP environment.

Your mission

Coordinate equipment and utilities qualification activities, ensuring compliance with applicable quality standards, regulatory requirements and project timelines.

Manage the technical content of equipment qualification documentation, including URS, SRS, DQ, IQ, OQ, PQ, qualification plans, reports and related documentation.

Act as a technical owner for assigned systems, providing technical support and addressing qualification-related questions and issues.

Assess projects, changes, modifications, deviations, investigations and non‑compliance issues to determine their impact on qualification activities.

Review and approve qualification documentation and executed test records, ensuring accuracy, completeness and compliance.

Collaborate with Quality Assurance and cross‑functional teams to ensure qualification documentation is reviewed and approved.

Monitor project progress, coordinate testing activities and ensure the availability of required resources and materials.

Manage deviations, corrective actions and quality issues using relevant quality management systems.

Maintain qualification processes, including periodic reviews, change evaluations and qualification lifecycle activities.

Contribute to continuous improvement initiatives, internal and external inspections, and qualification training activities.

Support team members through technical guidance, knowledge sharing and onboarding when required.

Ensure all activities are performed in accordance with Good Manufacturing Practices (GMP) and applicable regulatory guidelines.

Your profile

Degree in Engineering, Life Sciences, Biotechnology or a related technical field.

Experience in equipment qualification and commissioning within the pharmaceutical or biotechnology industry.

• Fluent in Dutch and English

Good knowledge of GMP requirements and relevant regulatory guidelines.

Experience with qualification documentation and testing activities, including IQ, OQ and PQ.

Knowledge of quality management processes, including deviations, change control, investigations and corrective actions.

Experience reviewing technical documentation and coordinating qualification activities across multidisciplinary teams.

Familiarity with quality management systems and documentation tools, such as TrackWise, is an asset.

Strong analytical and problem‑solving skills, with the ability to assess technical issues and identify appropriate solutions.

Good organisational skills, attention to detail and the ability to manage multiple activities and priorities.

Effective communication and collaboration skills, with the ability to work with technical and quality teams.

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.

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.

#LI-SK1

Who are we?

Job description

Join Amaris Consulting and contribute to challenging projects within the pharmaceutical and life sciences sectors. You will support qualification activities, ensuring that equipment and utilities meet quality standards and regulatory requirements in a GMP environment.

Your mission

• Coordinate equipment and utilities qualification activities, ensuring compliance with applicable quality standards, regulatory requirements and project timelines.
• Manage the technical content of equipment qualification documentation, including URS, SRS, DQ, IQ, OQ, PQ, qualification plans, reports and related documentation.
• Act as a technical owner for assigned systems, providing technical support and addressing qualification‑related questions and issues.
• Assess projects, changes, modifications, deviations, investigations and non‑compliance issues to determine their impact on qualification activities.
• Review and approve qualification documentation and executed test records, ensuring accuracy, completeness and compliance.
• Collaborate with Quality Assurance and cross‑functional teams to ensure qualification documentation is reviewed and approved.
• Monitor project progress, coordinate testing activities and ensure the availability of required resources and materials.
• Manage deviations, corrective actions and quality issues using relevant quality management systems.
• Maintain qualification processes, including periodic reviews, change evaluations and qualification lifecycle activities.
• Contribute to continuous improvement initiatives, internal and external inspections, and qualification training activities.
• Support team members through technical guidance, knowledge sharing and onboarding when required.
• Ensure all activities are performed in accordance with Good Manufacturing Practices (GMP) and applicable regulatory guidelines.

Your profile

• Degree in Engineering, Life Sciences, Biotechnology or a related technical field.
• Experience in equipment qualification and commissioning within the pharmaceutical or biotechnology industry.
• Fluent in Dutch and English
• Good knowledge of GMP requirements and relevant regulatory guidelines.
• Experience with qualification documentation and testing activities, including IQ, OQ and PQ.
• Knowledge of quality management processes, including deviations, change control, investigations and corrective actions.
• Experience reviewing technical documentation and coordinating qualification activities across multidisciplinary teams.
• Familiarity with quality management systems and documentation tools, such as TrackWise, is an asset.
• Strong analytical and problem‑solving skills, with the ability to assess technical issues and identify appropriate solutions.
• Good organisational skills, attention to detail and the ability to manage multiple activities and priorities.
• Effective communication and collaboration skills, with the ability to work with technical and quality teams.

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.

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.

#LI-SK1

Who are we?

Amaris Consulting isan independent technologyconsulting 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 of7,600 people spread across 5 continents and more than 60countries. 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!
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!