Msat engineer

3 weken geleden


Leiden, Nederland Oxford Global Resources Voltijd

Our client is an international biopharmaceutical organization dedicated to developing and producing high-quality drugs. With a strong focus on innovation, process optimization, and patients, the company aims to expand its manufacturing and technology operations. To strengthen the Manufacturing Science & Technology (MSAT) department, we are currently seeking a motivated Engineer MSAT Validation who will play a key role in maintaining and improving process performance and validation within a dynamic and regulated environment. Job Description As an Engineer MSAT Validation, you will be responsible for planning and executing validation activities related to manufacturing support processes. You will work within the Supporting Process Validation (SPV) team, focusing on the validation of equipment and systems such as cleaning, mixing, sterilization, and holding processes. In this role, you will collaborate closely with cross-functional teams to ensure that all validation procedures meet the highest regulatory and quality standards. You will contribute to continuous improvement initiatives, assist with the introduction of new technologies, and support audit readiness efforts. Your analytical mindset and attention to detail will ensure compliance, efficiency, and excellence across all technical validation activities. ResponsibilitiesDevelop, coordinate, and execute validation protocols for supporting processes such as cleaning, sterilization, mixing, and holding time studiesPrepare and review validation documentation, including protocols, reports, and technical assessmentsCollaborate with cross-functional teams to plan and schedule validation tasks and ensure alignment with project timelinesProvide technical input for process improvements, equipment qualification, and technology implementationSupport audits and inspections by ensuring documentation and validation records are complete and compliantEnsure adherence to internal policies, GMP guidelines, and applicable international regulatory standardsDrive continuous improvement initiatives within the validation and MSAT teams RequirementsBachelor's degree or equivalent in Biotechnology, Engineering, Life Sciences, or a related technical fieldMinimum of 2 years of relevant experience in the (bio)pharmaceutical industry or in an academic research environmentStrong understanding of validation principles and experience with related documentation and reporting practicesKnowledge of GMP regulations, quality standards, and validation guidelines (e.g., FDA, EMA, ICH, ASTM, ISPE, ISO)Excellent planning, coordination, and communication skillsAnalytical mindset with the ability to identify and resolve technical challengesExperience with Lean, Six Sigma, or other process optimization methodologies is a plus BenefitsRegion: South HollandContract: 1 year trough Oxford Global Resources, potential for extension or permanent hireWorking hours: Full-time position with hybrid working optionsSalary: between €3500 and €5500 gross monthly, based on experience and qualificationsOpportunity to work in a high-impact role within a global biopharmaceutical environmentInclusive, collaborative, and innovation-driven company cultureVacancy number: 26611


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