Qualification & Validation Engineer
il y a 2 jours
Qualification & Validation EngineerLocation: Louvain-la-Neuve, Belgium (Hybrid)About 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 Qualification & Validation Engineer, you will join a dynamic team within a leading life sciences environment. You will be responsible for planning, executing, and documenting qualification and validation activities for equipment, utilities, and processes in compliance with GMP and regulatory standards. This role requires strong technical expertise, attention to detail, and the ability to work cross-functionally in a fast-paced setting.The Role & ResponsibilitiesReporting to the project leadership team, your responsibilities will include:Developing and executing qualification and validation protocols (IQ/OQ/PQ) for equipment, utilities, and systemsPerforming risk assessments and ensuring compliance with GMP and regulatory requirementsManaging validation projects from planning to final reporting, including change controlCollaborating with engineering, production, and quality teams to ensure timely execution of validation activitiesTroubleshooting and resolving technical issues related to equipment qualification and process validationMaintaining accurate documentation and supporting audits and inspectionsDriving continuous improvement initiatives in validation processes and methodologies.Skills & QualificationsYou hold a Bachelor's or Master's degree in Engineering, Life Sciences, or related fieldYou have at least a minimum of 3 years of experience to 10 years in qualification and validation within a GMP-regulated environment (pharmaceutical or biotech)You have a first expoerience in validation principles, regulatory guidelines (EU GMP, FDA), and risk-based approachesAnd experience with equipment qualification, process validation, and computerized system validationYou work as a good organizer and project managerStrong communication skills and ability to work collaboratively across departmentsYou are fluent in both English and French.Your TeamYou will be part of a multidisciplinary team focused on ensuring product quality and regulatory compliance. The team collaborates closely with engineering, production, and quality assurance to deliver robust and reliable processes aligned with broader organizational goals.Recruitment ProcessBy applying for the Q&V Engineer position, you will go through the following steps in our recruitment process:First Screening: Olivia Braszko, Talent Acquisition Specialist, will review your resume and schedule an initial interviewTechnical Interview: You will meet with our Technical Director to discuss your expertise and technical skillsFinal Interview: A meeting with our Business Unit Director to confirm alignment with project and company values."If you are passionate about quality, compliance, and technical excellence, and want to contribute to a forward-thinking team, we'd love to hear from you"
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