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CSV Engineer

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Cognizant

1mo ago

  • Job
    Full-time
    Expert Level
  • Engineering
    IT & Cybersecurity
  • Cork

AI generated summary

  • You should have 10+ years in lab equipment support and validation, software gap analysis, knowledge of 21CFR Part 11, strong communication skills, and be detail-oriented and organized.
  • You will manage equipment validation projects, generate documentation, execute tests, collaborate on software configuration, and implement change control while ensuring compliance with quality standards.

Requirements

  • Minimum 10 years’ experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting.
  • Experience of analyzing and challenging s/w to identify gaps.
  • Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable.
  • Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
  • Self-motivated, detail-oriented, and excellent organizational and time management skills.
  • Capable of relating well to other people with whom s/he comes in contact, both within and outside of the laboratory area.

Responsibilities

  • Manage lab equipment validation projects from software install to business release.
  • Prioritize CSV activities in line with the project schedule and monitor budgets.
  • Generate computer system validation documentation, e.g. Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report, in accordance with site procedures and GMP guidelines.
  • Review of software release notes.
  • Liaise with service providers to determine successful installation of instrument software and ensure correct configuration.
  • Determine any specific configurations for the software, e.g. how data is saved and named.
  • Understand and define user permissions.
  • Execute test scripts, analyse test results and determine the acceptability of results against pre-determined criteria.
  • Work with the business to identify and implement procedural controls to mitigate issues found during testing.
  • Initiate and implement Change Control activities in accordance with Quality Standards and Practices.
  • Determine solutions or recommendations for changes and/or improvements.
  • Produce documentation that is well written and consistent throughout the document body e.g. headings, font type, font size, paragraph spacing, text alignment, correct tense.
  • Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required.

FAQs

What is the primary responsibility of a Lab Computer System Validation Engineer at Zenith Technologies?

The primary responsibility of a Lab Computer System Validation Engineer is to validate lab systems in Quality Control Labs and Manufacturing Operations, ensuring compliance and providing systems validation and compliance expertise for newly purchased and existing instruments.

What type of experience is required for this position?

A minimum of 10 years’ experience supporting and validating lab equipment, including updating documentation, system testing, and troubleshooting, is required.

Is experience in a regulated environment necessary for this role?

Yes, experience working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.

What qualifications related to regulatory standards should applicants possess?

Knowledge of 21CFR Part 11 requirements, Electronic Records/Electronic Signatures (ER/ES), and data integrity guidelines is desirable for applicants.

What skills are important for this role?

Strong oral and written communication skills, self-motivation, detail orientation, excellent organizational and time management skills, and the ability to build cross-functional relationships are important for this role.

What are some key tasks that the Lab CSV Engineer will be responsible for?

The Lab CSV Engineer will manage lab equipment validation projects, generate validation documentation, execute test scripts, analyze test results, liaise with service providers, and implement Change Control activities.

Will the Lab CSV Engineer need to collaborate with other teams?

Yes, the role involves working collaboratively with the Computerised Instruments team and liaising with the business to implement procedural controls.

What does the position entail regarding documentation?

The position entails generating and producing documentation that is well-written, consistent, and adheres to site procedures and GMP guidelines.

What are the expectations regarding environmental, health, and safety procedures?

The Lab CSV Engineer is expected to follow all relevant Environmental, Health, and Safety procedures and assist in incident investigations as required.

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Cognizant

Consulting
Industry
10,001+
Employees

Mission & Purpose

Cognizant is a multinational technology company that provides a wide range of IT services and solutions to organisations worldwide. Their primary focus is on helping businesses transform and thrive in the digital age. Cognizant's mission and purpose are centred around delivering innovative and cutting-edge technology solutions that drive client success. They offer services such as digital strategy, consulting, technology implementation, and IT outsourcing, enabling companies to adapt to evolving market dynamics, enhance operational efficiency, and deliver exceptional customer experiences. Cognizant's ultimate goal is to empower their clients with the tools, insights, and capabilities needed to navigate complex technological landscapes and achieve their business objectives in an increasingly digital world.