Commissioning, Qualification and Validation Engineer

il y a 2 semaines


Bruxelles, Belgique Nalys Temps plein

CQV Engineer – Senior Level Brussels, Belgium About Nalys Nalys is a fast-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 CQV Engineer, you will join a dynamic team working on the APS project within a GMP-regulated aseptic pharmaceutical facility. You will contribute to Commissioning, Qualification & Validation (CQV) activities, supporting the installation and qualification of lab and production equipment. This role is ideal for someone with a strong technical foundation and a desire to grow in the pharmaceutical industry. The Role & Responsibilities By reporting to the CQV project leadership and working closely with QA and engineering teams, your responsibilities will include: Qualification of the equipments (e.g., incubators, utilities, measuring devices) Preparation and execution of IQ/OQ/PQ protocols and supervise them Drafting and Updating the SOPs, Work Instructions, and Master Batch Records Preparing risk assessments (e.g., sterility assurance, contamination control, equipment) Coordinate procurement, installation, and qualification of equipment Audits preparation and QA compliance activities. Skills & Qualifications You hold a Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or Engineering You have a minimum of 5 years' experience in GMP-regulated pharma/biotech and in You act as an expert in validation/qualification processes and GMP expectations You have strong technical writing and documentation skills You are fluent in both English and French You live close to Brussels and are able to be on site 3 days a week. Soft Skills You have a detail-oriented mindset and are eager to learn Well organized, you have a problem-solving mindset You are adaptable to fast-paced project environments. Your Team You will be part of a multidisciplinary team focused on delivering high-quality CQV support for aseptic manufacturing processes. The team collaborates closely with engineering, QA, and operations to ensure compliance and operational readiness. The Recruitment Process By applying for the "CQV Support" position, you will go through the following steps in our recruitment process: Olivia Braszko, TA Specialist, will analyze your resume and cover letter and schedule a first screening You will have a second interview with our Technical Director The final interview will be with our Business Unit Director, Jimmy Rousseaux. "If you're passionate about pharmaceutical engineering and want to grow in a supportive and expert-driven environment, we'd love to hear from you"



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