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Posted 16 hours ago
Validation Engineer
Knightec GroupValideringsingenjör Life Science
Requirements
Engineering degree in biotechnology, medical technology, or similar, 3+ years of process validation experience in Life Science, Experience with DQ/IQ/OQ/PQ phases, Knowledge of GAMP5, 21 CFR part 11, and Eudralex Annex 11, Fluent in Swedish and English
Skills
ComplianceQuality AssuranceQuality ControlGMPClinical ResearchSix SigmaAI/MLGenAIData ScienceData EngineeringData managementData governanceMachine LearningDeep LearningNLP
About the role
Responsibilities
- Validation and qualification of processes, equipment, and computerized systems within the Life Science industry
- Participation in requirements setting, design, procurement, and commissioning
- Supporting customers through various roles using technical expertise
Requirements
- Engineering degree in biotechnology, medical technology, chemical engineering, computer engineering, or similar
- Minimum three years of experience independently driving process validation within Life Science
- Responsibility for DQ/IQ/OQ/PQ phases, focusing on CSV equipment, packaging, and cleanrooms
- Experience in requirements and deviation management
- Strong knowledge of GxP regulations, specifically GAMP5, 21 CFR part 11, and Eudralex Annex 11 and/or ISO13485
- Fluency in both Swedish and English
About the Company
Knightec Group is one of Northern Europe's leading strategic partners in product and digital service development, helping customers transform new technology into real-world solutions.
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Knightec Group · Malmö