CSV Engineer
- Company
- Proclinical Staffing
- Ort
- Switzerland
- Gehalt
- Negotiable
- Veröffentlicht
- Sonntag, 13. Juni 2021
- Ablaufdatum
- Sonntag, 27. Juni 2021
- Ref.
- 38198
- Kontakt
- Saulge Hubert
- Fachbereich
- Fertigung, Ingenieurwesen
- Stunden
- Vollzeit
- Vertragstyp
- Festanstellung
- Erfahrung
- Erfahren (keine Management-Erfahrung)
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A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector. Job ResponsibilitiesCreate the requested CSV documents according to the client SOPExecute the CSV test and support the CSV timelines with PM & CQV-LeadClose interaction with Process Engineers, Automation Team (EMR), PM and QAForcing the clients CQV/CSV approach during the entire projectActing as subject matter expert (SME) on following the clients CQV / CSV standardsCSV person of contact of the assigned system till the handover to the operation organisationParticipate to the system impact assessment as CSV SMEDefine with EMR and Package Units vendor the most appropriate design for vertical integration in the clients environmentCreate the requested CSV documents according to the clients SOP's and GuidelinesOrganise the reviews of the CSV documents till last QA approvalCreate the tests protocols and execute the testsClose collaboration with CSV Lead and CQV Lead EngineersSupervision for 3 employees (including contractors) Skills and RequirementsTechnical degree (Bachelor) in engineering or applied science, post graduate qualification preferred.Minimum of 5+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projectsWith biologics (mammalian, CGT)Chemical manufacturing technologies desirableExpertise in automation and vertical integration as well as data management under validated computer systemsVersed with planning CQV activities, leading large senior reports and high understanding/management of KPIs in regulated pharmaceutical industry and/or engineering companyStrong knowledge of ISPE GAMP5 and ASTM guidelines with proven experience on large and complex projects.Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
To ApplyProclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.#LI-SH1
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