CSV Application Specialist - Chromatography & LIMS

  • Full-time

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

Job Description

  • Identify the appropriate Commissioning and Qualification strategy to apply on specific project and define the list of activities required.
  • Define data backup policies to adhere with standard protocols for all generated data.
  • Account for backup and retrieval as per defined RTO and RPO.
  • Conduct risk assessments for computer systems, identify potential vulnerabilities, and implement risk mitigation strategies.
  • Understand the IT Operations in place and integrate application engineering, and installation and maintenance of networks, server, hardware, software, and telecommunications systems; and provides thought leadership in IT strategy.
  • Integrate strong IT security policies with internal applications.
  • Development of validation plans and testing documents to ensure accurate testing of chromatography (Empower) systems and related hardware with no critical audit observations.
  • Maintain Empower chromatography data systems for optimised availability.
  • Maintain validated state for applicable instrument data systems
  • Support activities that include but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ/OQ/PQ), Data Migration, SOPs and Change controls.
  • Perform cGMP compliance-based services specifically associated with Computerized Systems Validations & Data Integrity.
  • To implement GAMP compliant systems by adhering to current GAMP Software Validation standards
  • To implement or modify procedures and/or processes to solve business issues considering alternatives and limitations, environment and desired results.
  • To work on projects that may involve interfaces across diverse hardware platforms, with multiple programming languages, development tools or data access tools
  • To plan and prepare technical reports, memoranda, and instructional manuals as documentation of program development.

Qualifications

  • An understanding of applicable regulations such as Annex 11, GAMP and 21 CFR Part 11
  • Strong understanding of Windows operating systems
  • Strong understanding of system development life cycle
  • Ability to understand complex and abstract IT and business objectives to develop effective IT solutions, ability to program in one or more high-level languages
  • Proven experience in IT Infrastructure, ITIL, Project Management, etc.
  • Broad knowledge of security technologies, solutions, and tools (e.g., encryption technologies, SIEM, DLP, Anti-Virus, port scanners, vulnerability scanners, etc.).
  • Strong understanding of backup software as Veeam Backup and Replication, Acronis Backup.
  • Understanding of ISO 27001.

Additional Information

 

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.

Group's key figures are approx. 6.7 billion Euros turnover, over 940 laboratories across 59 countries and about 61,000 staff.

 

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