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
Clinical Scientific Expert
Dublin
Senior Maintenance & Reliability Eng
Dublin South
R&D Process Development Manager
Galway
French Customer Excellence & Medical
Cork
Staff Engineer-Customer R&D
Dublin
Senior Validation Engineer
Cork
Head of R&D
Galway
QC Team Leader
Cork
Environmental Health & Safety Lead
Louth
Clinical Publisher Associate
Cork
Product Development Scientist
Galway
Scientific Officer - Cyber Intelligence
Dublin
Qualified Person - Pharmaceutical
Cork
PLC Programmer
Limerick
Director of Quality Engineering (Medical
Limerick
R&D Engineer
Galway
Project Engineer
Limerick
Technical Program Manager
Dublin
Design Assurance Engineer
Galway
Aseptic Process Lead
Dublin
Project Engineer
Limerick
R&D Manager - Technologies for New P
Galway
Controls Engineer
Dublin South
Electronic Product Test Engineer-Hybrid/
Republic of Ireland
Senior CSV Specialist- Hybrid/Remote
Republic of Ireland
Manufacturing Engineer
Cork
Moulding Technican
Louth
Program Communications Manager - Remote
Republic of Ireland
Quality Engineer
Limerick
Senior R&D Engineer
Limerick City
Quality Engineer
Cork
Senior Lab Services Associate
Dublin
Microbiology Manager
Dublin
QA Specialist
Cork
R&D Manager
Galway
Supply Chain Project Lead
Limerick
Process Validation Engineer
Cork
R&D Engineer
Limerick City
Project Manager
Limerick
Business Excellence Lean Coach - Hybrid
Cork
Polymer Scientist
Limerick
Senior Manufacturing Engineer
Cork
Senior Validation Engineer
Limerick
Senior Quality Engineer
Limerick
CQV/Validation Engineer
Dublin
Project Engineer
Limerick
Manufacturing Specialist
Dublin South
Materials Engineer
Cork
Environmental Officer - Part-time or Ful
Kerry
R&D Engineer- Hybrid (60% WFT)
Galway
Biomedical Engineer
Dublin
Microbiology Manager
Waterford
GCP Inspector
Dublin
Senior Maintenance & Reliability Eng
Dublin South
Quality Engineer
Galway
Clinical Trials Contracts and Budgets As
Cork
Senior Electronic Engineer
Dublin
Quality Engineer
Clare
Process Engineer
Limerick
EHS&S Manager
Waterford
QC Separations Analyst
Cork
Lead Process Chemist
Westmeath
R&D Manager
Limerick
R&D Extrusion Engineer/Materials Eng
Galway
QC Analyst
Dublin
Supply Chain Associate
Dublin
Senior Manufacturing Engineer
Cork
NPD Manager
Galway
Process Engineer
Galway
Project Manager - Fully Remote - Value
Republic of Ireland
Manufacturing Process Specialist
Cork
Customer Excellence & Medical Soluti
Cork
Mechanical Engineer
Dublin
Chief Medical Scientist (Microbiology)
Dublin
System Architect
Galway
Quality Engineer
Galway
Senior Associate External Planning and D
Dublin
Senior CSV Specialist- Hybrid
Republic of Ireland
Project Engineer
Limerick
Quality Systems Specialist
Cork
Business Intelligence and Micro Automati
Cork
C&Q Engineer
Dublin
Clinical Trials Project Manager
Cork
Clinical Research Coordinator Medical De
Cork
R&D Engineer
Dublin
Manufacturing Quality Engineer
Galway
Director of Quality Engineering
Limerick
Regulatory Affairs Specialist
Cork
Manufacturing Engineer
Cork
Quality Systems Specialist
Galway
Production Team Lead
Dublin South
R&D Engineer
Galway
Vigilance Assessor
Dublin
Senior Quality Engineer
Cork
Project/Process Engineer - Purification
Cork
GMP Inspector
Dublin
Materials Characterisation Scientist
Galway
Senior Medical Writer
Dublin
Junior Research & Development Engine
Galway
Training Coordinator
Cork
Demand Planning Director
Cork
Design Assurance Engineer
Galway
Senior Project Engineer
Cork
Associate Director, Supply Chain
Dublin
Equipment Project Engineer
Limerick
Senior EHS Specialist
Cork
Automation Engineers (All Levels)
Limerick
Clinical Trial Associate German Speaking
Cork
EHS Specialist
Cork
Process Engineer
Republic of Ireland
Senior Supply Chain Manager
Limerick
Project Engineer
Cork
QA Contractor
Dublin City Centre
Senior Quality Systems Specialist
Galway
R&D Manager - Technologies for New P
Galway
Sales and Application Specialist (Micros
Dublin
Process Lead
Donegal
Project/Process Engineer - Purification
Cork
Senior R&D Engineer-New Product Deve
Westmeath
Design Assurance Engineer
Galway
Quality - Tech Transfer Specialist
Cork
Senior Production Engineer/Senior Manufa
Dublin
Quality Control Team Leader
Cork
EHS Trainer
Dublin
Technical Operations Engineer
Cork
Process Technician
Donegal
Controls Technician
Galway
Supply Network Senior Systems Analyst
Cork
Senior Quality Engineer
Dublin
Senior Manager- Field Correctives Action
Republic of Ireland
Mechanical Automation and Maintenance En
Cork
Clinical Sales Specialist (Diagnostics)
Dublin
Maintenance Engineer/ Technician
Dublin South
Engineering Technician
Dublin South
R&D Senior Program Manager
Galway
MDR/Vigilance Specialist
Galway
Microbiology Manager
Waterford
Quality Validation Engineer
Galway
PLC Programmer
Limerick
Project Readiness Lead
Limerick
Quality Assurance Specialist
Tipperary
Senior Associate QC
Dublin
Electronic Design Engineer
Galway
Regulatory Affairs Specialist
Republic of Ireland
NPI Manager
Dublin
Manufacturing Director
Dublin
Supply Chain Global Process Manager
Cork
Outcomes Sales Manager (Medical Devices)
Dublin
Project Manager - Life Cycle Management
Republic of Ireland
Director, Clinical Development (Oncology
South East
Associate Scientist
Cork
Dutch Customer Services Associate
Cork
Senior QA Specialist
Cork
Senior Validation Engineer
Limerick
Quality Specialist
Tipperary
Quality Engineer
Kildare
Sales and Applications Specialist (Scien
Dublin
Field Service Engineer
Dublin
R&D Director
Galway
Snr Associate QA
Dublin
QA Manager
Dublin
Quality Engineer
Limerick
Clinical Project Manager
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


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

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.