Browse by job sector

CSV Engineer

  1. West Coast
Seattle
  1. Contract
Competitive
  1. CAPEX Projects
33430

This vacancy has now expired

CSV Engineer - Pharmaceuticals - Seattle - 12-Month Contract 

Our client, a global biotechnology organisation, is recruiting for a CQV Engineer to join their capital project in the Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a CQV Engineer to help expand our client's biotech operations throughout the US. As the CQV Engineer you will be responsible for implementing all safety requirements for a new build facility.


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.

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 5.
  • 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.

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

 #LI-CO1
Save as a job alert
List #1

Similar Jobs

Risikomanager /in (m/w/d)

Salary

Competitive

Location

Berlin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Germany

Central Germany

Description

Risikomanager /in (m/w/d) - Deutschland - 18-monatige Vertragsposition Wir rekrutieren im Auftrag eines führenden globalen Pharmaunternehmens mit Sitz in der Umgebung von Germany. Aufgrund

Reference

36675

Expiry Date

01/01/0001

Read more
Read more
Harvest Systems Technical Project Manager

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

East Coast

Description

Harvest Systems Technical Project Manager - US, North Carolina - 12 Month Contract  Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of a Harvest Systems

Reference

37344

Expiry Date

01/01/0001

Davis Atkinson

Author

Davis Atkinson
Davis Atkinson

Author

Davis Atkinson
Read more
Read more
Purification Technical Project Manager

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

East Coast

Description

Purification Technical Project Manager - US, North Carolina - 12 Month Contract Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of a Purification

Reference

37346

Expiry Date

01/01/0001

Davis Atkinson

Author

Davis Atkinson
Davis Atkinson

Author

Davis Atkinson
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