Browse by job sector

CSV Engineer

  1. Dublin
Dublin
  1. Contract
Competitive
  1. CAPEX Projects
06-06-2024
34121

This vacancy has now expired

CSV Engineer - Pharmaceuticals - Dublin - 12-Month Contract 

One of the top 10 best companies to work in Ireland is looking for more engineers for their large-scale new facility north of Dublin. Is this you?

An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.


Responsibilities: 
  • Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
  • Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
  • Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
  • Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
  • Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
  • Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.
  • Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.
  • Stay updated with industry trends, regulatory changes, and advancements in computer system validation practices.

Requirements: 
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
  • Familiarity with validation methodologies, including risk-based validation approaches.
  • Proficiency in creating and executing validation protocols and documenting validation activities.
  • Excellent analytical and problem-solving skills, with attention to detail.
  • Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
  • Ability to work independently and manage multiple projects simultaneously.
  • Knowledge of software development life cycle (SDLC) and change control processes.
  • Understanding of data integrity principles and practices.

If this role is of interest to you, please apply now! 

  #LI-JS4  
Save as a job alert
List #1

Similar Jobs

QC Biologist

Salary

Competitive

Location

Milton Keynes

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

East Anglia

Description

QC Biologist - Pharmaceuticals - 12-Month Contract  Do you want to be involved with exciting Pharmaceutical projects? When it comes to the development and production of veterinary vaccines,

Reference

34674

Expiry Date

01/01/0001

Tom Evans

Author

Tom Evans
Tom Evans

Author

Tom Evans
Read more
Read more
MEP Site Manager

Salary

Competitive

Location

Berlin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

East Germany

Description

MEP Site Manager - Berlin - 12-Month Contract  We have an unmissable opportunity to work with a company that delivers technology expertise and high-end solutions to data centre construction

Reference

34660

Expiry Date

01/01/0001

Charlotte Clarke

Author

Charlotte Clarke
Charlotte Clarke

Author

Charlotte Clarke
Read more
Read more
MEP Project Manager

Salary

Competitive

Location

Berlin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

East Germany

Description

MEP Project Manager - Berlin - 12-Month Contract  We have an unmissable opportunity to work with a company that delivers technology expertise and high-end solutions to data centre construction

Reference

34659

Expiry Date

01/01/0001

Charlotte Clarke

Author

Charlotte Clarke
Charlotte Clarke

Author

Charlotte Clarke
Read more
Read more

Insights

life sciences testing laboratory

Why you should work in Commissioning, Qualification and Validation
Read more

02/07/2023

Your next step as a Validation Engineer
Read more

07/20/2021

pharmaceutical factory construction

Working in an organisation from Start Up Phase

Read more

06/28/2021

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV