Job Specifications
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.
Company: One of Our Clients
Job Description:
Position Title: Computer System Validation Engineer
Duration: 06+ months (Extendable)
Location: Bothell, WA 98021 (Hybrid (3 days a week onsite) and required to be onsite throughout UAT execution)
Pay Rate: $70.00 - 75.00/hr on W2
Top 3-5 Skills ( Must Have)
Strong Computer Systems Validation (CSV) experience, Familiarity with Manufacturing Execution Systems (MES), Protocol drafting and execution, good communication
PURPOSE 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 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 assigned
REQUIRED 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).
Education and Experience:
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.)
Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for the Fastest Growing Business in the US
12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)
About the Company
Net2Source (N2S) is a global workforce solutions company recognized by SIA as the largest and fastest-growing Total Talent Solutions provider with a presence in 32 countries. and in-house Glo-Cal (global and local) teams to support our clients.
We carve out custom talent solutions, keeping People, Process, and Technology as the pillars of making the process simple, robust, and efficient. With over 3,500+ contractors working worldwide, we specialize in Contingent Staffing, RPO, Direct Sourcing, Payroll Solutions (EOR/AOR), ...
Know more