Project Manager / Compliance Engineer - Life Sciences (Flanders)

ALTEN Belgium is a leading consultancy company in the fields of Life Sciences, Engineering and IT in which our people and clients are central.

In our open and adaptable organization, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.

All employees together form a large network of expertise, even at an international level. In this way we offer optimal growth to our consultants and the best solutions for our customers.

We are currently looking for a Project Manager / Compliance Engineer for one of our clients.

We are currently looking for a Compliance Engineer / Project Manager to lead the commissioning and qualification of parenteral process equipment used in pharmaceutical manufacturing. The position is based in the Kempen region and involves working on a variety of systems for the parenteral dosage forms. The successful candidate will ensure that all equipment and processes meet applicable regulatory, quality, and safety standards throughout their lifecycle.

Main Responsibilities:

• Define and align project scope, timelines, and budget with stakeholders.
• Author and review key project documentation, including User Requirements Specifications (URS), Risk Assessments, Project Qualification Plans, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, as well as Qualification Summary Reports.
• Propose and defend qualification and validation strategies to Quality Assurance and project teams.
• Implement commissioning strategies to optimize and streamline the qualification process.
• Execute and coordinate qualification and commissioning activities, including on-site fieldwork such as P&ID verification, functional testing, and system walkthroughs.
• Work with a range of systems and equipment including isolators, filling lines, freeze dryers and CIP/SIP systems.

Tools & Systems:

• OSI-PI, Veeva Vault, SAP, PAS-X MES, COMET.

Your profile:

• Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
• +6 years of proven experience in equipment qualification, commissioning, and validation within the pharmaceutical industry.
• Strong knowledge of cGMP, regulatory guidelines, and quality standards.
• Hands-on experience with pharmaceutical process equipment.
• Experience with project management, including scope definition, planning, and budget control.
• Strong communication and problem-solving skills.
• Fluent in Dutch and English (written and spoken).

What ALTEN has to offer

• A permanent contract
• A salary package in line with your experience and extra benefits (company car, meal vouchers, recovery days, insurances)
• The possibility to join a great team and be part of the success story of an international group

Apply now and be a part of our amazing journey. We believe in growing together!

We are looking forward to getting to know you and your ambitions!