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D05 - ENGINEERING / VALIDATION - Computer System Validation Engineer

ECLARO

Bothell, WA

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JOB DETAILS
SALARY
$76.61–$81.25 Per Hour
SKILLS
Acceptance Testing, Biology, Business Solutions, Clinical Support, Code of Federal Regulations, Communication Skills, Computer Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Relations, Delivery Management, Dental Insurance, Diversity, Documentation, Documentation Plan, Drug Manufacturing, ERP (Enterprise Resource Planning), Genetics, GxP, Healthcare, IT Service Management (ITSM), Information Technology & Information Systems, Interpersonal Skills, Laboratory Equipment, Laboratory Systems, Manufacturing, Manufacturing Execution Systems (MES), Manufacturing Systems, Medical Products, Oracle, Presentation/Verbal Skills, Problem Solving Skills, Process Validation, Quality Management, Regulations, Regulatory Compliance, Requirements Management, Requirements Validation/Verification, Risk, SAP, ServiceNow, Software Development Lifecycle (SDLC), Standard Operating Procedures (SOP), System Validation, Systems Engineering, Team Player, Technical Support, Test Scripts, Validation Plan, Vision Plan, Writing Skills
LOCATION
Bothell, WA
POSTED
Today
Computer System Validation Engineer
Job Number: 26-00988
 
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Computer System Validation Engineer for our client in Bothell, WA. 
 
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • 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.
  • Hybrid (3 days a week onsite) and required to be onsite throughout UAT execution
 
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 Qualifications:
  • 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.)
 
Pay Rate: $76.61-$81.25/Hour
 
If hired, you will enjoy the following ECLARO Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
 
If interested, you may contact:
Paul Quibuyen
Christian.Quibuyen@eclaro.com
6466952942
Paul Quibuyen | LinkedIn
 
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.
 

About the Company

E

ECLARO

Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:

• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities

Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:

• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services

Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.

Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
http://www.eclaroit.com

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