Commissioning, Qualification and Validation Engineer
il y a 5 jours
CQV Engineer – Senior LevelBrussels, BelgiumAbout NalysNalys 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 DescriptionAs 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 & ResponsibilitiesBy 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 themDrafting and Updating the SOPs, Work Instructions, and Master Batch RecordsPreparing risk assessments (e.g., sterility assurance, contamination control, equipment)Coordinate procurement, installation, and qualification of equipmentAudits preparation and QA compliance activities.Skills & QualificationsYou hold a Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or EngineeringYou 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 expectationsYou have strong technical writing and documentation skillsYou are fluent in both English and FrenchYou live close to Brussels and are able to be on site 3 days a week.Soft SkillsYou have a detail-oriented mindset and are eager to learnWell organized, you have a problem-solving mindsetYou are adaptable to fast-paced project environments.Your TeamYou 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 ProcessBy 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 screeningYou will have a second interview with our Technical DirectorThe 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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Commissioning, Qualification and Validation Engineer
il y a 5 jours
Brussels, Belgique Nalys Temps pleinCQV Engineer – Senior LevelBrussels, BelgiumAbout NalysNalys 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...
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