Quality Assurance Validation Engineer

Bend, OR 97701

Posted: 11/14/2023 Employment Type: Direct Hire Division: Life Sciences Job Number: JN -112023-17907 State: Oregon

Job Description

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Quality Assurance Validation Engineer:
  • Title: Quality Assurance Validation Engineer
  • Location: Bend, OR
  • Industry: Life Science/Pharmaceutical
  • Salary: Based on Experience
  • Employment Type: Direct Hire
Job Overview:
The Quality Assurance Validation Engineer to support validation activities of Quality Control and Operations instrumentation within GMP manufacturing. In this role you will be part of a cross functional team that will be involved in the development, execution, and/or approval of qualification and / or validation of facilities, utilities, equipment, process, cleaning, and computerized systems. You will also support validation lifecycle activities and will participate in the generation, review and/or approval of change controls, CAPAs, and deviations.
  • Generates and/or supports the generation of risk assessments, user requirements specifications (URS), validation plans, change requests, SOPs, CAPAs, and other relevant documents
  • Supports validation lifecycle activities to ensure that qualified systems remain in their validated state
  • Leads data integrity risk assessments efforts for validated computerized systems
  • Leads the validation effort of enterprise and analytical systems at Ser n
  • Provides assessments and recommendations related to systems integration needed to preserve the integrity of the data lifecycle
  • Supports the qualification/validation effort driven by the MSAT group
  • Provides support during clients and regulatory audits
  • Bachelor s degree in science, engineering, or related field with 3-5 years of experience in the pharmaceutical industry
  • At least three years of experience performing qualifications and/or validations
  • Comprehension of current regulations and guidelines (e.g., 21 CFR Part 11, EudraLex Volume 4 - Annex 15, GAMP 5, etc.) and how to apply them to support the validation effort
  • Technical writing skills to effectively develop procedures, discrepancies, change controls, CAPAs and associated documents needed to support the validation effort
  • Hands-on experience with a minimum of two of the following: qualification of facilities, utilities, equipment and/or computerized systems, cleaning or process validation
  • Experience performing data integrity risk assessment is preferable
  • Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team
  • Understanding of IT systems, services, and infrastructure is preferred
  • Strong time-management skills and the ability to organize and coordinate multiple projects at a time
  • Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems
  • Physical Requirements
  • Prolonged periods sitting at a desk and working on a computer
  • Prolonged periods of mobility between offices and campus buildings
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
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