Role: Sr. CSV Engineer, Trackwise
Location: Seattle Washington
Type: Contract
Length: 1 year at least
As a Computer Systems Validation (CSV) Consultant you will:
- Apply your professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in pharmaceutical and biotech Manufacuring and other GxP and GAMP regulated environments
- Perform as a project execution and thought leader to provide regulatory guidance regarding compliance with intended specifications
- Engage in value-add relationships to deliver outstanding project outcomes and identifying new more optimal opportunities for processes and procedures
- Share best practices, industry knowledge, and personal expertise to educate client in formal and ad hoc settings
Requirements:
- Demonstrated capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures
- Experience with Trackwise Digital (Cloud based solution)
- Demonstrated experience planning and scheduling validation and validation lifecycle deliverables, test execution, and deviation management considering computer software assurance (CSA) principles
- Professional knowledge of 21CFR Part 11 systems validation and regulatory compliance with a range of computerized systems in GxP and GAMP regulated environments
- Strong experience with GAMP and ability to share and execute new GAMP protocols
- Experience with Data Integrity impacts on Validations including Audit Trail Risk Assessment
- Flexibility and adaptability - work on the full validation lifecycle in oversight and hands-on roles, and can stretch into new roles when asked
- Bachelor's or 4-year degree from an accredited college or university
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.