ABOUT US

Dynavax GmbH is a medium-sized biotechnology company in Düsseldorf that was founded more than 30 years ago. We are part of the US American Dynavax Technologies Corporation. Since the foundation, we are a strategic cooperation partner of well-known global biotech and pharmaceutical companies and are specialized in the development and production of vaccines. To strengthen our team at the Düsseldorf site, we are looking for new talents (f/m/d) in full-time.

Senior IT GxP Specialist (f/m/d)

PRIMARY PURPOSE OF POSITION:

The Senior GxP IT Systems Specialist is responsible for GxP IT systems and ensuring systems are implemented and managed in accordance with GxP requirements, Dynavax policies and operating procedures.

MAJOR DUTIES OF POSITION:

Administrator / System Owner for GxP Applications
IT Subject Matter Expert (SME) for new projects impacting GxP applications and environments
SME / local representative within global IT and Computerized System Procedures
Generate, review and manage life cycle documentation for IT-Systems (e.g. Standard Operating Procedures, Work Instructions, Functional Documentation)
Provide IT input into Computer System Validation (CSV) for GxP systems
Identify and implement compliance improvements and upgrades within IT systems / processes
Coordination between IT team and internal customers
Investigator for IT related deviations and IT SME on deviations led by other departments
Change Control / CAPA Owner for IT activities
Generate and manage IT Changes for site
Stay up to date with current industry practice on GxP IT environments / systems, and where required introduce new and improved practices to Dynavax

KNOWLEDGE AND SKILL REQUIREMENTS:

Technical education/ studies in IT, Automation or related subject or equivalent education
Experience of deploying and managing Laboratory Information Management Systems (LIMS) in a GxP environment
Experience of working with cloud based systems, mainly Software as a Service (Saas)
Broad understanding of IT infrastructure as it supports IT systems (e.g. network, virtualization)
Conversational level German both written and spoken is required as a minimum (B2)
Fluent spoken and written English
IT experience within the Pharmaceutical industry (minimum 3 years)
Excellent interpersonal and communication skills, and ability to work as part of a team
Strong ethical foundation and a sound compliance understanding

Benefits

Jobrad
Fitnessmitgliedschaft (auch online)
Mitglied bei Corporate Benefits GmbH (Rabatte für Mitarbeiter von mehr als 1500 Firmen)
freie Kalt- und Warmgetränke (Kaffee, Tee, Wasser)
Weihnachts- und Sommerparty (in non-Corona-Zeiten)
Mitarbeiter-Frühstück (in non-Corona-Zeiten)
Saisonale Mitarbeiter Aufmerksamkeiten
Kostenloses Parken

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Ansprechpartnerin:
Frau Maike July
Tel: +49 211 75845 162

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Aktualisiert am 20.09.2023

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