Computer System Validation Engineer

Net2Source (N2S); Bothell (WA); On-site; USD 96,432 - 103,320; Full time

Job summary

Net2Source (N2S) is seeking a Computer System Validation Engineer to lead validation activities for GxP electronic systems in Bothell, WA. The ideal candidate will have at least 4 years of strong Computer Systems Validation experience and familiarity with Manufacturing Execution Systems.

This role is vital for ensuring compliance with industry regulations and documentation standards. A Bachelor’s degree in life sciences or a related field is mandatory, alongside excellent communication skills.

Qualifications

• 4+ years of direct experience with CSV activities.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations.
• Demonstrated success in a high-performing environment.

Responsibilities

• Lead validation activities for GxP electronic systems.
• Develop requirements and specifications for computerized systems.
• Ensure documentation aligns with internal procedures.

Skills

Strong Computer Systems Validation (CSV) experience

Familiarity with Manufacturing Execution Systems (MES)

Ability to communicate effectively

Education

Bachelor's degree in a life sciences or engineering / IT discipline

Tools

SAP

Oracle

Veeva

Job description

Overview

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

Job title: Computer System Validation Enginee

rLocation: Bothell, WA 9802

1Duration: 06+ Months (Extendable

)
Pay Rate: $70.00 – 75.00 hr on

W2

Top 3-5 Skills ( Must H

ave)Strong Computer Systems Validation (CSV) experi

enceFamiliarity with Manufacturing Execution Systems (

MES)Protocol drafting and execution, good communica

tion

PURPOSE AND SCOPE OF POSI

TION: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 regulat

ions.

DUTIES AND RESPONSIBILITIES

• Author, review and/or approve applicable CSV documen
• tationAssist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal proc
• eduresAssist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP oper
• ationsOther related duties as as

REQUIRED COMPETENCIES: Knowledge, Skills, and Abi

• lities:Ability to effectively communicate with both technical and non-technical team m
• embers.Strong interpersonal skills, especially regarding teamwork, client focus, verbal and written commun
• icationKnowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation pra
• ctices.Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufac
• turing.Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. Servi
• ceNow).Knowledge and exposure to Business Quality Management Systems (i.e.
• Veeva).Strong technical and problem-solving skills and the ability to work indepen
• dently.Demonstrated success working in a high-performing, business results-driven envir
• onment.Understanding of computer system vali
• dation.Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. Info
• Batch).Understanding of computer system validation

(CSV).
Education and Exp

• erience: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 si
• gnaturesStrong knowledge on Manufacturing Execution System (MES) val
• idation.Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / si
• gnaturesStrong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOP

s, etc.)
Awards and A

ccolades:America's Most Honored Businesses

(Top 10%)Awarded by USPAAC for the Fastest Growing Business

in the US12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 20

19, 2020)Fastest 50 by NJ Biz (2020, 20

19, 2020)INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to t

his 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 Agile12018 Best of the Best Platinum Award

by Agile12018 TechServe Alliance Excellence Awar

ds Winner2017 Best of the Best Gold Award by Agile1(Ac

t1 Group)