Job description
About the job
We are seeking a Qualification Engineer to support equipment qualification activities in a GMP-regulated manufacturing environment. The role involves executing IQ, OQ, and PQ activities, preparing and reviewing GMP qualification documents, and collaborating with cross-functional teams including Engineering, Manufacturing, Quality, and Validation.
Your missions
- Support qualification activities for manufacturing equipment used in GMP production.
- Execute and document IQ, OQ, and PQ activities.
- Prepare and review qualification protocols, test scripts, reports, and other GMP documents.
- Work closely with Engineering, Manufacturing, Quality, Validation, and Maintenance teams.
- Support equipment readiness checks, risk assessments, deviation handling, and qualification strategy discussions.
- Ensure all qualification work follows GMP, GDP, and data integrity requirements.
- Review and support approval of documents related to the equipment qualification and validation lifecycle.
- Good to have: Experience with pharmaceutical or biotech processing equipment such as bioreactors, chromatography systems, ultrafiltration/filtration systems, hold tanks, vessels, or other GMP manufacturing equipment.
Your profile
- Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related discipline.
- Minimum 2–3 years of experience in manufacturing equipment qualification within pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments.
- Hands-on experience with equipment qualification activities, including IQ, OQ, PQ, validation documentation, and qualification lifecycle management.
- Good understanding of GMP, GDP, deviation management, change control, and data integrity principles.
- Ability to independently review, execute, and manage qualification protocols and related documentation.
- Strong communication and stakeholder management skills, with the ability to collaborate across cross-functional teams.
- Experience in CQV projects, technology transfer, or new facility/equipment setup will be an added advantage.
- Exposure to biologics, sterile manufacturing, API, or vaccine manufacturing environments is preferred.
- Experience supporting audits, inspections, or regulatory readiness activities is an advantage.
- Fluent in English, both written and spoken.
What we offer
- An international community, bringing together 110+ different nationalities
- An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
- A robust training system with our internal Academy and 250+ available modules
- A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
- At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.
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!