QA Validation QC Engineer

Il y a 5 heures

Wavre, Wallonia, Belgique Nalys Temps plein

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Validation Engineer – QA Validation QC, Utilities & Facilities 📍 Brabant Wallon, Belgium About Nalys Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed. Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.

Job Description
As a Validation Engineer, you will join the QA Validation department of a leading pharmaceutical manufacturer in Belgium, supporting a strategic active substance remediation program. You will provide quality oversight across the validation lifecycle, from strategy definition through documentation review to on-the-floor presence during validation and requalification runs. This role sits at the interface between validation engineering, production, and quality, requiring both technical rigor and the ability to navigate a complex, multi-stakeholder environment. You will help ensure that validation activities are executed logically, safely, and in full compliance with GMP requirements. The Role & Responsibilities Working closely with the validation and quality teams, your responsibilities will include:
- Providing QA oversight throughout validation activities linked to the remediation program, including field presence during validation and requalification runs
- Actively contributing to the definition of validation strategies, in line with internal quality requirements
- Reviewing and approving validation documentation, including validation plans, validation summary reports, URS, FMEA, IQ/OQ and PQ protocols and reports, and Periodic Reviews where applicable
- Building a solid understanding of the technical challenges of the remediation program to help shape the right implementation and validation approach
- Planning your workload in line with both project and routine schedules
- Ensuring validation activities are carried out in a logical and chronological sequence
- Actively participating in follow-up meetings and troubleshooting discussions to anticipate risks and contribute to solutions
- Providing QA oversight on the methods implemented
- Supporting deviation investigations and root-cause troubleshooting
- Coaching colleagues and supporting knowledge transfer across projects and routine activities. Skills & Qualifications
- You hold an engineering or university degree in biotechnology, agronomy, chemistry, or pharmacy
- You have at least 5 years of experience in an aseptic, laboratory, industrial, quality, or production environment
- You have experience working within a regulated environment such as cGMP
- You have hands-on experience in industrial validation, including cleaning-specific documentation
- A first experience or qualification in a QA Validation role within a similar large-scale pharmaceutical environment is a strong asset
- You are comfortable adapting to complex, multi-interface environments
- You have solid knowledge of GMP and aseptic environments, production equipment, closed systems, and Utilities & Facilities technologies
- You bring a project-level, risk-based quality mindset
- You have strong analytical skills and the ability to anticipate issues
- Your communication, oral and written, is clear and effective in English and French
- You are solution-oriented, proactive, and able to negotiate, with a critical mindset. The Recruitment Process By applying for the "Validation Engineer" position, you will go through the following steps in our recruitment process: 1. Olivia Braszko, TA Specialist, will analyze your resume and schedule a first screening to assess your motivation and answer all of your first questions 2. You will have a second interview with one of our Technical Experts 3. The last interview will be with our Director Life Sciences, Jimmy Rousseaux. If you're driven by quality and want to play a key role in a strategic validation program within a world-class pharmaceutical environment, we'd love to hear from you

QA Validation QC Engineer

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