Sr. CSV Engineer, Trackwise

4 days ago

Bothell, United States IT Solutions LLC Full time
Role: Sr. CSV Engineer, Trackwise
Location: Seattle Washington
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.

s a Computer Systems Validation (CSV) Consultant you will:
  • pply 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.

  • Sr Engineer, Software

    4 weeks ago

    Bothell, United States T-Mobile Full time

    At T-Mobile, we invest in YOU Our Total Rewards Package ensures that employees get the same big love we give our customers. All team members receive a competitive base salary and compensation package - this is Total Rewards. Employees enjoy multiple wealth-building opportunities through our annual stock grant, employee stock purchase plan, 401(k), and access...

  • Sr Engineer, Software

    4 weeks ago

    Bothell, United States T-Mobile Full time

    At T-Mobile, we invest in YOU Our Total Rewards Package ensures that employees get the same big love we give our customers. All team members receive a competitive base salary and compensation package - this is Total Rewards. Employees enjoy multiple wealth-building opportunities through our annual stock grant, employee stock purchase plan, 401(k), and access...

  • Sr Engineer, Software

    2 months ago

    Bothell, United States T-Mobile Full time

    At T-Mobile, we invest in YOU! Our Total Rewards Package ensures that employees get the same big love we give our customers. All team members receive a competitive base salary and compensation package - this is Total Rewards. Employees enjoy multiple wealth-building opportunities through our annual stock grant, employee stock purchase plan, 401(k), and...

  • Computer Validation Specialist

    7 months ago

    Bothell, United States Omni Inclusive Full time

    Job Title: Computer Validation Specialist Location: Bothell, WA*ONSITE*Local candidates preferred TOP SKILLS: • 3-5+ years' experience in performing periodic review of computerized systems. • Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred. • Experience with development of CSV documentation (Validation Plans,...

  • Sr Engineers, Systems Reliability

    4 weeks ago

    Bothell, United States T-Mobile Full time

    Career Band: L08 Be unstoppable with us! T-Mobile is synonymous with innovation-and you could be part of the team that disrupted an entire industry! We reinvented customer service, brought real 5G to the nation, and now we're shaping the future of technology in wireless and beyond. Our work is as exciting as it is rewarding, so consider the career...

  • Software Engineering Expert

    3 days ago

    Bothell, Washington, United States T-Mobile Full time

    OverviewT-Mobile is a leading provider of innovative communication services. As a Sr Software Engineer, you will play a crucial role in shaping the future of our software solutions.About the RoleWe are seeking an experienced Sr Software Engineer to join our team. In this position, you will work with a collaborative group of engineers to design, implement,...

  • Senior Electrical Engineering Professional

    2 days ago

    Bothell, Washington, United States Unavailable Full time

    About the RoleThis is an exciting opportunity for a talented Sr. Electrical Engineer to shape and support our mission by designing, developing, and testing electrical equipment, components, circuits, or systems.

  • Avionics System Engineer​

    4 weeks ago

    Bothell, United States Belcan Full time

    ​​Sr. Avionics System Engineer​ Job Number: 351749 Category: Systems Engineering Description: Job Title: ​​Sr. Avionics System Engineer​ Location: Bothell. WA Zip Code: ​​98011​ Start Date: Right Away Job Type: Direct Hire Pay Rate: $110k - 150K/salary DoE Keywords: #AvionicsEngineer #SystemsEngineeringJobs JOB...

  • Senior Engineering Specialist

    1 week ago

    Bothell, Washington, United States FUJIFILM Diosynth Biotechnologies Full time

    About the RoleWe are seeking an experienced Sr Mechanical Engineer to lead the design and development of our next-generation transducers. As a key member of our engineering team, you will be responsible for planning and executing technical projects, developing NPI packaging methods, and improving the thermal efficiency of new and existing transducers.Your...

  • Systems Infrastructure Engineer

    2 days ago

    Bothell, Washington, United States General Dynamics - Ordnance and Tactical Systems (WA) Full time

    Job SummaryWe are seeking a highly motivated and experienced Sr. Systems Engineer to join our team at General Dynamics - Ordnance and Tactical Systems (WA). As a key member of our engineering team, you will work closely with internal and external customers to develop system/subsystem architectural models, define requirements and verification methods, and...

  • Senior Full Stack Engineer

    2 days ago

    Bothell, Washington, United States T-Mobile Full time

    Job Title: Senior Full Stack EngineerCompany Overview:T-Mobile is a company that values innovation and collaboration. Our Total Rewards Package includes a competitive base salary and compensation package, along with multiple wealth-building opportunities through our annual stock grant, employee stock purchase plan, 401(k), and access to free money...

  • Lead Software Engineer Opportunity

    3 days ago

    Bothell, Washington, United States T-Mobile Full time

    As a Sr Software Engineer at T-Mobile, you will play a critical role in shaping the future of our software solutions. We are seeking an experienced engineer with a strong background in software development and a passion for delivering high-quality results.Responsibilities include designing, developing, and deploying software solutions using various...

  • Sr Avionics System Engineer

    2 weeks ago

    Bothell, United States Greenpoint Technologies Full time

    Job DescriptionJob DescriptionSummaryCreates advanced designs of avionics to include cabin system components, in-flight entertainment, communication systems, LED cabin lighting, AC/DC power systems and products to meet customer criteria, design quality standards, FAA requirements, budget, and project schedules.Essential Duties and ResponsibilitiesCreates a...

  • Sr Engineer, Software DevOps Lead

    2 months ago

    Bothell, United States T-Mobile Full time

    Be unstoppable with us! T-Mobile is synonymous with innovation-and you could be part of the team that disrupted an entire industry! We reinvented customer service, brought real 5G to the nation, and now we're shaping the future of technology in wireless and beyond. Our work is as exciting as it is rewarding, so consider the career opportunity below as your...

  • Sr Manager, Solution Engineer

    1 month ago

    Bothell, United States Pfizer Full time

    At Pfizer we make medicines and vaccines that change patients' lives with a global reach of over 780 million patients. Pfizer Digital is the organization charged with winning the digital race in the pharmaceutical industry. We apply our expertise in technology, innovation and our business to support Pfizer in this mission. The Biopharma, Patient & CDI (C4)...

  • Sr. Electricity Market Optimization Software Engineer

    4 weeks ago

    Bothell, United States GE Vernova Full time

    Job Description Summary In this role, you will work closely with a team of 8-15 people who are responsible for enhancing, evolving, and supporting large on-premise highly-available Electricity Market Management System (MMS). The team includes power systems, database, software, and optimization engineers. As a Senior Electricity Market Optimization Software...

  • Electrical Systems Design Lead

    2 days ago

    Bothell, Washington, United States Unavailable Full time

    OverviewWe are seeking a highly motivated and experienced Sr. Electrical Engineer to join our team at General Dynamics Ordnance and Tactical Systems (GD-OTS) in Bothell, WA.

  • Technical Solutions Architect

    3 days ago

    Bothell, Washington, United States T-Mobile Full time

    About the OpportunityWe are excited to offer a challenging and rewarding opportunity for a Sr Engineer, Software to join our team at T-Mobile. This role involves working on cutting-edge software projects and contributing to the growth and success of our company.Job DescriptionIn this role, you will work with a team of experienced software engineers, network,...

  • Senior Software Development Professional

    1 week ago

    Bothell, Washington, United States T-Mobile Full time

    About the JobWe are looking for a talented Sr Engineer, Software to join our team at T-Mobile. This is an excellent opportunity for someone who wants to work on challenging software projects and contribute to the growth and success of our company.Job SummaryIn this role, you will work closely with other software engineers, network, and systems engineers to...

  • Senior Avionics Design Lead

    3 days ago

    Bothell, Washington, United States Belcan Full time

    About the JobWe are seeking a highly skilled Sr. Avionics Design Lead to join our team at Belcan. As a key member of our avionics and electrical systems group, you will be responsible for leading the design and development of complex systems for VIP and commercial aircraft.About the Role:Lead the design and development of avionics and electrical...