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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Computer Validation Specialist

Job Description

  • Type: Contract
  • Job #76359

Our client, a leading pharmaceutical company, is hiring a Computer Validation Specialist consultant on a contract basis.

Work Location

Bothell, WA/Hybrid


Hybrid on-site / remote position. The Computer Systems Validation (CSV) Engineer works cross-functionally to lead and execute validation activities for GxP electronic systems and applications. This role is an individual contributor. The CSV Specialist 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 Specialist will have primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant client procedures and regulations. This includes coordination of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes to existing systems.

The position has the following requirements:
• Bachelor’s degree in a life sciences or engineering discipline or equivalent industry experience
• 2+ 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 of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records and electronic signatures
• Familiar with development of CSV documentation (Validation Plans, Requirements / Specifications / Assessments, Test Scripts [IQ / OQ / PQ], Summary Reports, Trace Matrices, SOPs, etc.)
• Familiar with diverse computerized systems, such as computer-controlled laboratory instruments (stand-alone), MES, ERP, LIMS, Validation Lifecycle Management Software, QMS
• Experience in following CSV methodology for system evaluations, changes and implementations
• Ability to work independently
• Experience implementing controls directly supporting Data Integrity efforts is a plus
Primary Duties and Responsibilities:
• Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.
• 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
• Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required)
• Other related duties as assigned

Pay Range: $ 65-67


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