CSV Engineer

2 weeks ago

Cork, Cork, Ireland Westbourne Full time

Overview

The Validation Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations.

We are seeking an enthusiastic and experienced validation engineer to join our team on a long-term contract basis. The Validation Engineer will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments.

The position will work within a collaborative Computerized Instruments team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.

Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.

Desired Background/Experience/Attributes

  1. Minimum 3 years' experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting
  2. Experience of analyzing and challenging s/w to identify gaps.
  3. Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable
  4. Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
  5. Self-motivated, detail-oriented and excellent organizational and time management skills
  6. Capable of relating well to other people with whom s/he comes in contact, both within and outside of the laboratory area

Roles And Responsibility

  1. Manage lab equipment validation projects from install to business release
  2. Prioritize validation activities in line with the project schedule and monitor budgets
  3. Generate computer system validation documentation in accordance with site procedures and GMP guidelines
  4. Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
  5. Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
  6. Work with the business to identify and implement procedural controls to mitigate issues found during testing
  7. Initiate and implement Change Control activities in accordance with Quality Standards and Practices
  8. Determine solutions or recommendations for changes and/or improvements
  9. Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
#J-18808-Ljbffr

  • Csv Engineer

    4 days ago

    Cork, Cork, Ireland Cognizant Technology Solutions Ireland Full time

    Do you have lab equipment validation experience, and are you seeking a new job in Cork?Cognizant is looking for an IT CSV Engineer, and the hybrid role comes with an attractive salary and benefits package, including the chance to join a collaborative team.The IT CSV Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing...

  • CSV Engineer

    3 weeks ago

    Cork, Cork, Ireland Cognizant Life Sciences Manufacturing Full time

    Cognizant is seeking an agile, passionate and experienced CSV Engineer to join our team on a long-term basis. This full-time hybrid role comes with a favorable salary and the opportunity to explore flexible working arrangements. You'll be responsible for validating Lab Systems in QCL Labs and Manufacturing Operations.As a CSV Engineer, you will provide...

  • IT CSV Engineer

    3 weeks ago

    Cork, Cork, Ireland Cognizant Life Sciences Manufacturing Full time

    Do you have lab equipment validation experience, and are you seeking a new job in Cork? Cognizant is looking for an IT CSV Engineer, and the hybrid role comes with an attractive salary and benefits package, including the chance to join a collaborative team.The IT CSV Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing...

  • CSV Engineer

    3 weeks ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    A CSV Engineer – IT Labs is required to join a global biotech company based in Co. Limerick. This role will be fully on site in a brand new state-of-the-art manufacturing facility and will play a critical role in ensuring that computerized instrument systems are in full compliance with regulatory requirements, company policies and procedures, and will...

  • CSV Engineer 1554

    6 days ago

    Cork, Cork, Ireland SimoTech Full time

    +353-21-4834930 Specialists in Life Science Automation and IT SystemsStay Connected :SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery,...

  • CSV Systems Engineer

    6 days ago

    Cork, Cork, Ireland Cognizant Technology Solutions Ireland Full time

    Cognizant Technology Solutions Ireland is recruiting an IT CSV Engineer to support our operations team in Cork. As a key member of our team, you will be responsible for validating lab equipment and systems to ensure compliance with regulatory requirements.This involves managing lab equipment validation projects from software installation to business release,...

  • CSV Engineer

    3 weeks ago

    Cork, Cork, Ireland Cognizant Life Sciences Manufacturing Full time

    Senior Talent Acquisition Specialist specializing in Internal Recruitment and CRM at CognizantCognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst...

  • CSV Validation Engineer

    2 weeks ago

    Cork, Cork, Ireland Cognizant Technology Solutions Ireland Full time

    Job Overview:Cognizant is seeking a talented IT CSV Engineer to join our team in Cork. As a key member of our team, you will be responsible for validating lab equipment and updating documentation, as well as system testing and troubleshooting.Main Responsibilities:Validate lab equipment and update documentation to ensure compliance with regulatory...

  • CSV/QA Tester

    3 weeks ago

    Cork, Cork, Ireland Cognizant Life Sciences Manufacturing Full time

    Cognizant is seeking an agile and experienced CSV/QA Tester to join our collaborative team on a long-term contract basis. This full-time hybrid role based in Cork comes with a favorable salary and benefits package.As a CSV/QA Tester, you will assess software quality on newly purchased and existing QCL and production Lab Instruments. You will conduct testing...

  • CSV System Validator

    1 week ago

    Cork, Cork, Ireland Cognizant Technology Solutions Ireland Full time

    About this Role:The IT CSV Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations. This is a hybrid role that comes with an attractive salary and benefits package. The successful candidate will have a minimum of 3 years of experience in supporting and validating lab equipment, updating documentation, system...

  • Csv Audit Trails

    4 days ago

    Cork, Cork, Ireland Cognizant Full time

    Computerised Systems Engineer Zenith Technologies, now a Cognizant Company, is a world leader in delivering digital transformation solutions to Life Sciences.Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies whilst maintaining compliance.Our...

  • CSV Validation Specialist

    5 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    A Senior IT Labs Engineer is required to join Life Science Recruitment based in Co. Limerick. This role will be fully on site in a brand new state-of-the-art manufacturing facility and will play a critical role in ensuring that computerized instrument systems are in full compliance with regulatory requirements, company policies and procedures, and will drive...

  • CSV Audit trails

    3 weeks ago

    Cork, Cork, Ireland Cognizant Full time

    Computerised Systems EngineerZenith Technologies, now a Cognizant Company, is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies whilst maintaining compliance. Our...

  • CSV Audit trails

    6 days ago

    Cork, Cork, Ireland Cognizant Full time

    Computerised Systems EngineerZenith Technologies, now a Cognizant Company, is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies whilst maintaining compliance. Our...

  • CSV Engineer

    2 days ago

    Cork, Cork, Ireland Cognizant Life Sciences Manufacturing Full time

    We are seeking a highly motivated and experienced CSV Engineer - Lab Systems to join our team. In this role, you will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations.About the RoleYou will provide systems validation and compliance expertise for newly purchased instruments. Your responsibilities will include...

  • CSV/QA Validation and Verification Professional

    5 days ago

    Cork, Cork, Ireland Cognizant Life Sciences Manufacturing Full time

    This role requires a skilled CSV/QA Validation and Verification Professional to ensure the quality of software used in life sciences manufacturing. The successful candidate will work closely with cross-functional teams to validate software, identify gaps, and develop test plans.Key responsibilities include:Analyzing system specifications, design documents,...

  • Lab IT CSV Engineer 1504

    5 days ago

    Cork, Cork, Ireland SimoTech Full time

    SimoTech provides manufacturing automation and IT systems engineering, project management, and validation services. We partner with life sciences companies to design, build, operate, and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility, and achieve regulatory...

  • Life Science IT Engineer

    5 days ago

    Cork, Cork, Ireland SimoTech Full time

    Job RequirementsWe are looking for a highly experienced CSV Engineer with 10+ years of experience in Pharmaceuticals or Biopharmaceuticals, process automation, and GAMP, GDP AND cGMP environments.Key Qualifications:Education: Degree level qualification in Science, Engineering or equivalent.Experience: 10+ years of CSV experience in Pharmaceuticals or...

  • IT Validation Engineer

    3 days ago

    Cork, Cork, Ireland Cognizant Technology Solutions Ireland Full time

    About the RoleWe are looking for an experienced CSV Engineer to lead the validation of Lab Systems in QCL Labs and Manufacturing Operations. The successful candidate will provide systems validation and compliance expertise for newly purchased instruments.Manage lab equipment validation projects from software install to business releasePrioritize CSV...

  • Validation Engineer Professional

    6 days ago

    Cork, Cork, Ireland Cognizant Life Sciences Manufacturing Full time

    Cognizant Life Sciences Manufacturing is seeking a skilled professional to fill the position of CSV Engineer. This full-time role offers a unique opportunity to work in a collaborative environment with a favorable salary and flexible working arrangements.As a CSV Engineer, you will be responsible for providing systems validation and compliance expertise for...