CVS Application Specialist (Chromatography & LIMS)

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.

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.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

CVS APPLICATION SPECIALIST - CHROMATOGRAPHY & LIMS

Job Description

This role will provide user and administrative support for applications and will provide IT expertise in analysing existing system processes and suggesting & implementing improvements.

This person must be able to work well in isolation or in a team structure and be comfortable with committing to and meeting realistic milestones. They will have good communications and customer service skills, particularly for user support.

Job Responsibilities

• 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.

• Test and adhere to internal Data integrity protocols for all generated data.

• 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.

• Maintain SOP’s and WIs for applicable instrument data systems.

• Provide training support for new and existing instrument data systems.

• Continue to provide enhancements (i.e. customised reports) to instrument data systems that will improve quality and increase productivity.

• Assist and provide support for training of users on Empower chromatography system upgrades.

• 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.

• Manage, co-ordinate, develop and execute the validation deliverables for new GxP computerized systems.

• To assist in deployment and configuration of IT System Projects with Expert Users.

• To implement GAMP compliant systems by adhering to current GAMP Software Validation standards.

• To analyse current operational procedures and identify opportunities for improvement.

• To prepare workflow charts and diagrams to specify in detail the operations to be performed by equipment and computer programs and operations to be performed.

• 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.

• To ensure that all documentation is completed on time, accurately and legibly.

• To keep their training records up to date and to initiate training where possible.

• To update any relevant documentation as required.

• To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.

• To handle any customer related queries where necessary and liaise with the team to solve these queries if needed.

Qualifications

• Degree or equivalent in Information Technology with laboratory experience or Degree or equivalent in a scientific discipline with strong Information Technology experience

Experience / Skills

• 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.

• Ability to learn new programming languages and systems quickly.

• 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.

• Ability to learn and use cGMP compliant work practices and systems.

• Capability to learn new software and systems by reading and understanding technical manuals and instructions.

• Ability to use problem-solving skills.

• Ability to meet urgent timelines.

• Strong software development and business analysis skills.

• Excellent communication (oral and written) and attention to detail.

• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.

• Ability to learn new techniques and technologies, keep accurate records, follow procedures, and comply with company policies Good communication skills both internally and externally.

• Ability to understand customers’ requirements and to be able to devise and articulate the most appropriate solutions.

Company Benefits

• Additional holiday leave

• Birthday day

• Attendance award

• Paid Maternity Leave

• Marriage leave

• Free Tea & Coffee

• Training and Development

• Study support

• Free parking

• Income protection

• Death in service

• Sports & Social Club

• Corporate Social responsibility day

• Salary and bonus reviewed annually

• Paid Sick leave

• Finder’s Fee

• Recognition program

• Health insurance (Dependent on length of service/role)

• Contributory pension (Dependent on length of service/role)