D05 - ENGINEERING / VALIDATION - Computer System Validation Engineer
- Bothell, WA
- Permanent
- Full-time
Who We Are
Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision-Right Talent. Right Time. Right Place. Right Price.Job Description: Hybrid (3 days a week onsite) and required to be onsite throughout UAT executionPURPOSE AND SCOPE OF POSITION:
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 the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with the relevant Client procedures and regulations.DUTIES AND RESPONSIBILITIES:
· Author, review and/or approve applicable CSV documentation
· Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
· Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
· Other related duties as assignedREQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Ability to effectively communicate with both technical and non-technical team members.
- Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
- Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).
- Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
- Strong technical and problem-solving skills and the ability to work independently.
- Demonstrated success working in a high-performing, business results-driven environment.
- Understanding of computer system validation.
- Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).
- Understanding of computer system validation (CSV).
· Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
· Strong knowledge on Manufacturing Execution System (MES) validation.
· Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
· Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)The starting hourly compensation for this assignment is within the range of ***/hr to ***/hr. Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not Client). Factors influencing this decision may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location of the job. Compensation details are subject to change.
Additional Job Requirements:
NoneWhy Work With Us?
We believe in more than just jobs-we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.
Our Commitment to Inclusion & Equity
Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.
Awards & Recognition
- America's Most Honored Businesses (Top 10%)
- Fastest-Growing Staffing Firm by Staffing Industry Analysts
- INC 5000 List for Eight Consecutive Years
- Top 100 by Dallas Business Journal
- Spirit of Alliance Award by Agile1
Click Apply Now and let's make it happen.Best regards,
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