I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Ruth Holland
Life Science

01 507 9255
[email protected]
Connect with me on
Hot Science Jobs
Senior Reguatory Specialist
Galway City
R&D Senior Program Manager
Galway
Product Development Scientist
Galway
Senior QC Microbiology 24/7 Shift
Dublin
Senior Manager
Dublin
Lab Services Team Lead
Dublin
Process Technician
Donegal
C&Q Engineer
Dublin
Senior R&D Engineer
Dublin
Senior Validation Engineer
Limerick
Maintenance Technician- Nights
Galway
Quality - Tech Transfer Specialist
Cork
Senior Project Manager - Manufacturing
Cork
Project Engineer
Limerick
Design Assurance Engineer
Republic of Ireland
Warehouse Manager
Dublin
Sales Specialist (Pharmaceutical: Multi-
Longford
Operations Manager
Donegal
Technical Operations Specialist (Process
Cork
Design Assurance Engineer
Galway
Process Engineer
Galway
Senior Technical Sales Specialist
Kilkenny
Senior Regulatory Affairs Specialist
Galway City
Electronic Design Engineer
Galway
Process Team Lead
Donegal
Head of R&D
Galway
Manufacturing Engineer
Limerick
R&D Manager - Technologies for New P
Galway
Process Engineer
Limerick
R&D Vision Scientist
Galway
Quality Specialist
Tipperary
Senior Polymer Development Engineer
Galway
Territory Account Manager (Gynaecology)
Dublin
NPD Manager
Galway
Senior Process Development Engineer
Galway
Director, Clinical Development (Oncology
South East
Senior Regulatory Affairs Specialist
Dublin
Maintenance Engineer/ Technician
Dublin South
Quality Engineer
Limerick
R&D Mechanical Technician
Galway
QC Bioassay Analyst
Cork
R&D Engineer
Limerick City
Process Lead
Donegal
QA Contractor
Dublin City Centre
Project Manager
Kildare
Quality Engineer
Wexford
Engineering Shift Technician
Dublin
R&D Director
Galway
Snr Facilities Engineer
Dublin South
Manufacturing Quality Engineer
Galway
Site Microbiologist EO Sterilisation
Roscommon
R&D Extrusion Engineer
Galway
R&D Engineer
Galway
NPD Manager
Galway
Medical Information Associate Fluent Spa
Cork
Commissioning and Qualification Engineer
Dublin
Quality Engineer
Limerick
Senior Regulatory Affairs Specialist
Dublin
Business Development Manager (North Lein
Dublin
Senior Supply Chain Manager (On site)
Dublin
Manufacturing Director
Dublin
Senior CSV Specialist- Hybrid
Republic of Ireland
Clinical Central Services and Innovatio
Cork
Global Head of R&D
Republic of Ireland
R&D Manager
Galway
Associate Scientist
Cork
GCP Inspector
Dublin
Senior Facilities Engineer
Dublin South
Project Engineer
Limerick
Principal CAD Experience
Dublin
Quality Control Team Leader
Cork
Controls Engineer
Dublin South
EHS Specialist
Cork
Senior R&D Engineer
Galway
R&D Engineer
Galway
Process Team Lead
Donegal
Manager Engineering & Strategic Proj
Donegal
Senior Project Engineer - Equipment Proj
Limerick
Project Engineer
Cork
Senior Manager Clinical Operations
Dublin
Project Manager
Limerick
R&D Manager
Galway
Director of Quality Engineering
Limerick
Maintenance Technician- Nights
Galway
Project Engineer
Limerick
Operations Manager
Galway
Qualified Person - Pharmaceutical
Cork
Assoc MDR/Vigilance Specialist
Galway
Project Engineer - Innovation Centre
Cork
Senior Manufacturing Engineer
Cork
Senior R&D Engineer
Dublin
R&D Engineer- Hybrid (60% WFT)
Galway
Quality Engineer
Galway
CSV Engineer
Limerick
Senior Manufacturing Engineer
Galway
Senior Associate Quality Assurance
Dublin
R&D Engineer
Dublin
Electrical Design Engineer
Galway
Process Team Lead
Donegal
R&D Manager
Galway
Principal R&D Engineer
Dublin
Principal/Senior R&D Engineer Cathet
Galway
Senior Manufacturing Engineer -Coatings
Limerick
Production Supervisor
Kildare
Qualified Person
Cork
System Architect
Galway
Clinical Evaluator
Republic of Ireland
Head of Quality, RP
Dublin
Senior Medical Director Immunology
Cork
Quality Engineer
Galway
Senior Process Engineer
Cork
Manufacturing Specialist
Dublin South
Senior R&D Engineer
Limerick City
Innovation Grant Project Coordinator
Galway
Senior Manufacturing Engineer
Cork
Quality Assurance Specialist
Tipperary
Quality Control Team Leader
Cork
Senior Program Manager - Sustainability
Cork
Engineering Technician
Dublin South
Commissioning and Qualification Lead - F
Dublin
Controls Engineer
Dublin South
Electrical Design Engineer
Galway
Quality Systems Analyst
Cork
TMF Projects Associate - French
Cork
Senior Business Development Manager (Cel
Kilkenny
Senior Engineering Manager
Limerick
Senior R&D Engineer-New Product Deve
Westmeath
R&D Manager
Galway
Maintenance Engineer/ Technician
Dublin South
Production Team Lead
Dublin South
Fluent French and Arabic Customer Excell
Cork
Quality Engineer
Dublin
Quality Systems Specialist
Galway
Senior Electronic Engineer
Dublin
Senior R&D Clinical Engineer
Republic of Ireland
Customer Excellence & Medical Soluti
Cork
Facilities Maintenance Technician
Dublin South
NPD Manager
Galway
Snr Supplier Quality Engineer
Galway
R&D Science and Innovation Leader
Galway
Automation Strategy Manager
Cavan
Engineering Technician
Dublin South
Sales/Customer Service Administrator
Clonmel
Process Validation Engineer
Cork
Senior Validation Engineer
Dublin
QC Team Leader
Cork
Senior Automation Engineer
Dublin South
Principal Research Engineer
Galway
Engineering Technician
Dublin South
Equipment Mechanical Design Engineer
Galway
New Product Introduction Program Manager
Galway
Project Engineer
Limerick
Clinical Research Scientist - Medical Af
Cork
R&D Engineer
Galway
Controls Engineer
Dublin South
Global Manager Innovation Quality
Galway
Senior Manufacturing Quality Engineer
Dublin
Senior Product Development Engineer
Galway
Project Engineer
Limerick
Manufacturing Engineer
Galway
Clinical Development Lead
Dublin
Manufacturing Engineer
Wexford
Environmental Officer - Part-time or Ful
Kerry
Operations Engineer
Dublin
Senior Manager Clinical Central Services
Cork
Process Scientist
Cork
Supply Chain Associate
Dublin
QC Leader
Cork
Associate Director, Supply Chain
Dublin
Publications Scientific Communications A
Cork
EH&S Specialist
Longford
Design Quality Engineer
Galway
Regulatory Affairs Director
Dublin
Regulatory Affairs Specialist
Republic of Ireland
Senior Quality Assurance Specialist
Dublin
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Senior CSV Specialist- Hybrid/Remote


Reference:/RH/AWIO-738258 Location: Republic of Ireland
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Validation Coordinator, Validation Engineer, Validation Specialist

Life Science Recruitment is hiring for aSenior CSV Specialist to join our clients expanding Life Sciences division.You will join our high-performance team of Technical Engineers and work within an expanding team providing cutting-edge solutions to clients. You will work collaboratively with our customers to scope, plan, implement and refine solutions specific to requirements.

Responsibilities:

  • Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment (Pharma, Medical Devices, Biotech)
  • Work directly with our clients to perform gap analysis / early engagement assessments to understand the required scope of full assessments
  • Conduct CSV Assessments / Health Checks to assess compliance and report back to senior stakeholders with findings and suggested solutions
  • Resolution of fundamental Computer System Validation (CSV) compliance issues derived from implementation of 21 CFR Part 11 automated controls/functionalities in legacy systems
  • Ensure all project related issues and deviations are documented and approved
  • Ensure computer system validation activities completed are compliant with internal procedures and external regulations and standards.
  • Review and approve documents prepared by project teams, other departments and contractor organizations
  • Assist in development of validation strategy and validation plan for computer system validations.
  • Assist with change control activities in accordance with site procedures
  • Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with system changes and new technology development.

Qualifications and Experience:
  • Relevant third level qualification or equivalent work experience
  • Above 8 years’ Computer System Validation experience including lead experience
  • Development and review of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, Reporting)
  • Ability to lead a team of CSV consultants in a consulting environment

Skills:
  • Client-facing skills
  • People management skills - introducing and building ways in which people can learn from each other, encouraging mentoring and the transfer of knowledge by designing and delivering learning interventions
  • Team work and emotional intelligence
  • Good self-management – continuous performance is both an objective and a mind-set
  • Has an innovative approach – a bold thinker and doer, matching creativity with vigilance
  • High value on openness and transparency


Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required.
No visa sponsorship will be offered with this role.

Call Ruth Holland on 087 7822 198 for more details.