Skip to main content

CSV Lead

  1. United States
Seattle
  1. Contract
Competitive
  1. CAPEX Projects
34235

This vacancy has now expired

CSV Lead - Pharmaceuticals - Seattle, USA - 6-Month Contract 

Our client, a global biotechnology organisation, is recruiting for a CSV Lead to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a CSV Lead to help expand our client's biotech operations throughout USA. As the CSV Lead you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.


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-CO1
Save as a job alert
List #1

Similar Jobs

Production Operator

Salary

Competitive

Location

County Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Dublin

Description

Production Operator - Pharma - Dublin - 11 months + possible extension  This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with

Reference

36065

Expiry Date

01/01/0001

Dawn Hosier

Author

Dawn Hosier
Dawn Hosier

Author

Dawn Hosier
Read more
Senior Electrical Project Manager

Salary

Competitive

Location

Groningen

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Netherlands

North

Description

Senior Electrical Project Manager - Northern Netherlands - 12-Month Contract Are you a Senior Electrical Project Manager looking for your next contract role? We have a fantastic opportunity

Reference

35719

Expiry Date

01/01/0001

Gary Bartholomew Read more
Senior MEP Project Manager

Salary

Competitive

Location

Groningen

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Netherlands

North

Description

Senior MEP Project Manager - Northern Netherlands - 12-Month Contract Are you a Senior MEP Project Manager looking for your next contract role? We have a fantastic opportunity for you to join

Reference

35720

Expiry Date

01/01/0001

Gary Bartholomew Read more

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.