Valideringsingenjör Life Science
hace 2 semanas
Om rollen
Vi söker en valideringsingenjör som kommer att spela en nyckelroll i att hjälpa våra kunder och säkerställa att processer och system uppfyller de högsta kvalitets- och säkerhetsstandarderna.
Uppdraget
Planera och genomföra valideringsaktiviteter för utrustning, processer och system.
Vara med och ta fram valideringsdokumentationen så som planer och protokoll.
Samarbeta med tvärfunktionella team för att säkerställa att valideringskrav uppfylls.
Granska och godkänna kvalificeringsprotokoll och rapporter (IQ/OQ/PQ).
Medverka i eller leda processriskanalyser.
Krav
En ingenjörsexamen inom bioteknik, medicinsk teknik, kemi eller relaterat område.
Minst 3 års erfarenhet av validering inom life science-industrin.
God kunskap inom GxP-regelverken.
Har du även kunskap inom GAMP5, 21 CFR part 11 och Eudralex Annex 11 är det meriterande.
Erfarenhet av riskanalyser (ex. ISO 14971 och FMEA) är meriterande.
Stark analytisk förmåga och problemlösningsförmåga.
Goda kunskaper i engelska och svenska, både i tal och skrift.
Om oss
Vi är ett tekniskt konsultföretag som erbjuder tjänster och produkter till företag inom en rad olika branscher.
I Uppsala arbetar vi primärt inom medicinteknik och Life Science med utveckling av produkter som på ett eller annat sätt skapar samhällsnytta.
Vi är ca 50 medarbetare inom system, mjukvara, hårdvara, elektronik, kvalitet och projektledning och vi sitter centralt på Kungsgatan I Uppsala, nära tåget och nära kunderna.
Ansök
Vi träffar löpande potentiella kollegor, så skicka in din ansökan redan idag.
Vid frågor om rollen eller om du vill veta mer om hur det är att vara en del av Prevasfamiljen, är du varmt välkommen att höra av dig till rekryterande chef.
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