Sr. CSV Engineer, Trackwise Job at I.T. Solutions, Inc., Seattle, WA

WVVZelhGUXF2REY0WEpKWmw0SlFMRGw4Smc9PQ==
  • I.T. Solutions, Inc.
  • Seattle, WA

Job Description

Role : Sr. CSV Engineer, Trackwise

Location : Seattle Washington(Onsite)

Type : Contract

Length : 1 year at least

Description: Seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant!

Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.

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

Job Tags

Contract work,

Similar Jobs

The Wayfinder Hotel

Line Cook Job at The Wayfinder Hotel

 ...We are looking for someone passionate about the culinary arts to join our Culinary team . This individual must be creative, motivated, and passionate about growing their talents in the kitchen! Successful candidates for this role will have previous experience... 

Ansible Government Solutions

Ambulatory Care Outpatient Registered Nurse (RN) Job at Ansible Government Solutions

 ...LLC (Ansible) is currently recruiting multiple Ambulatory Care Outpatient Registered Nursesto support the Atlanta VA Health Care Center located...  ...s degree is preferred Has been practicing actively as an RN in an outpatient setting for at least the last threeyears... 

Gravity IT Resourcing

GRC Analyst Job at Gravity IT Resourcing

 ...Job Title: GRC Analyst Job Type: Contract Location: Juno Beach, FL Responsibilities Manage risk and vulnerability assessments, validation testing, compliance reviews, and audits in accordance with NIST standards Maintain and monitor a central repository... 

ROGERS ENTERPRISES, INC.

Retail Recruiter Job at ROGERS ENTERPRISES, INC.

 ...work experience as a Recruiter (either an in-house recruiter or staffing agency. Solid ability to conduct different types of interviews (...  ...with various selection processes - in person interviewing, online interviews, phone interviewing, reference checks etc. Familiarity... 

Good Samaritan Society

RN Weekend Supervisor - Prescott Valley - FT - Days Job at Good Samaritan Society

 ...Careers With Purpose Join our not-for-profit organization that has provided over 100 years of housing and services to seniors with a commitment to quality care and service in a Christian environment. Facility: GSS AZ Prescott Vly Location:...