Browse by job sector

CSV Engineer

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. Life Sciences
37983
Apply to this job Save job
CSV Engineer - Ireland, Dublin - Long Term Contract

One of the top 10 best companies to work in Ireland is looking for CSV Engineer for their large-scale new facility in 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 include:
  • 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.
  • Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems.
  • Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation.
Key requirements include:
  • 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 5.
  • Requires extensive 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.
  • Experience in Sterile Drug Product manufacturing and associated equipment / utilities / laboratory instruments / IT Infrastructure . enterprise systems.
  • Experienced in computer systems validation (CSV) from requirements to through release of SCADA / PLC controlled equipment (i.e. filling lines, isolators, Lyophilisers)
  • Experienced in computer systems validation (CSV) of Emerson DeltaV.
  • Completion of Electronic Record Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments for equipment/utility systems.
  • Experienced in the use of paperless validation and test tools such as ValGenesis, Kneat, ALM.
If this role is of interest, please apply now!

#LI-JS4
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Communication Consultant

Salary

Competitive

Location

Copenhagen

Salary

Competitive

Sector

Life Sciences

Job type

Contract

Location

Denmark

Description

Communication Consultant - Denmark, Copenhagen - 6-12 Month Contract Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Communication Consultant to join their new and

Reference

37967

Expiry Date

01/01/0001

Dev Chauhan

Author

Dev Chauhan
Dev Chauhan

Author

Dev Chauhan
Read more
Read more
BMS Engineer

Salary

Competitive

Location

Copenhagen

Salary

Competitive

Sector

Life Sciences

Job type

Contract

Location

Denmark

Description

BMS Engineer - Denmark, Copenhagen - 10 Month Initial Contract Our client, a global pharmaceutical company, are looking for a BMS Engineer to join their team. The company has grown to become a

Reference

37959

Expiry Date

01/01/0001

Abigail Stier

Author

Abigail Stier
Abigail Stier

Author

Abigail Stier
Read more
Read more
C&Q Area Lead - HVAC/Cleanrooms

Salary

Competitive

Location

Dublin

Salary

Competitive

Sector

Life Sciences

Job type

Contract

Location

Ireland

Dublin

Description

C&Q Area Lead - HVAC/Cleanrooms- South Dublin - 12 Month Contract  Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of C&Q Area Lead - HVAC/Cleanrooms.

Reference

37803

Expiry Date

01/01/0001

Rheanon Wight

Author

Rheanon Wight
Rheanon Wight

Author

Rheanon Wight
Read more
Read more

Insights

QCS Staffing Validation Engineer Jobs: In-Demand Skills and Career Paths

Validation Engineer Jobs: In-Demand Skills and Career Paths
Read more

05/27/2025

QCS Staffing A Guide to Pharmacovigilance Careers

A Complete Guide to Pharmacovigilance Careers
Read more

05/15/2025

Living and working in Ireland
Read more

03/12/2025

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