Job Information
Actalent Computer System Validation Engineer in Bothell, Washington
Computer System Validation Engineer
The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor.
The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle.
The CSV Contractor has primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant procedures and regulations.
This includes coordination of system validation periodic reviews, audit activities, and support of computer system validation efforts for new system implementations and changes to existing systems.
Hard Skills
Strong knowledge on MES systems i.e. Emerson Syncade and ERP systems i.e. SAP or Oracle
Familiar with development of CSV documentation (Validation Plans, Requirements Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, SOPs, etc.)
Knowledge of cGMP, GXP, GAMP including 21CFR part 11 and good documentation practices
Knowledge of IT service management platforms to support change IT operational events i.e. ServiceNow
Knowledge and exposure to Business Quality Management Systems i.e. Veeva
Job Type
This is a contract position with a duration of 52 Weekly.
Work Environment
On-site at Bothell, WA. Large manufacturing site working with various cross-functional teams
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.