Validation Engineer - MA - 5 openings

  • Software Specialists
  • Andover, MA, USA
  • Mar 17, 2019
Contractor Engineering

Job Description

Title: Validation Engineer - MA - 5 openings

Duration: 10 Months Contract with possible extension or Hire

Location: Andover, MA

Pay Rate: $45.00 - $53.00/hr on w2 with no benefits

Comments from the HM:

  • Writing validation documents
  • Reviewing validation documents
  • Asses the validation documents
  • Evaluation of existing document - related to compliance
  • Finding information by interacting with all the business resources throughout the country (12 locations)
  • Should have knowledge with regulation - 13485, 14971, 21 CFR part (Required)
  • Gamp 5 preferred
  • IQ/OQ/PQ - must have
  • Validation summary reporting - must have
  • Risk assessment - must have
  • Background in software not required

Description:

  • The Validation Engineer role will work closely with the Software Validation Management Team, other Q&R personnel and various project teams throughout the organization and across multiple sites. In this role, you will help provide regulatory guidance and perform project management duties to ensure all software validation projects and corresponding deliverables adhere to current regulations, industry standards, and Policies within the Monitoring Analytics & Therapeutic Care Business Group

You are responsible for:

  • Participate in all CSV related projects within the MA&TC scope in support of achieving company objectives and ongoing commitment to quality
  • Act as a Project Manager and Lead CSV initiatives as assigned; perform activities to ensure CSV activities are performed, scheduled, planned, resourced and completed in accordance to established timelines
  • Work closely with other Q&R members, IT personnel, system business owners, end users, etc. to provide adequate support and expertise; communicate effectively and clearly throughout all levels of the organization
  • Guide stakeholders on software validation/quality relevance to establish suitable validation requirements and deliverables in accordance to FDA regulations and GAMP 5 principles
  • Assist in generating and maintaining a complete and accurate inventory of all validated systems, including comprising components, validation deliverables and relevant meta data and system ownership information ensuring the validated state of each system is readily known at all times
  • Perform and/or oversee CSV risk management activities; author/review risk assessments and perform risk mitigation activities as deemed appropriate
  • Ensure Legacy systems are properly maintained and compliant based on current industry requirements and policies
  • Measure and monitor CSV progress to senior management; generate reports and metrics as assigned
  • Work with records personnel to ensure all validation deliverables are accessible and easily retrievable if needed during an internal/external quality audit
  • Work with Document Control and Training Coordinators to assure concise CSV training materials are controlled, assigned, and maintained appropriately