Validation Engineer

Organization: PQE Group

Location: 
Chicago IL
US

Commitment: 
Full Time

Description: 

Responsibilities

  • Ensures IT validation packages are inspection ready and in compliance with applicable Company policies and procedures.
  • Works autonomously with related IT contacts and the business process SMEs for this purpose.
  • Supports as SQA the testing and implementation of regulated IT applications.
  • Ensures continuous improvement and gives input related to the validation strategy for IT changes.
  • Collaborates with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.

Minimum Experience/Training

  • Proficient in understanding of GXP regulations and validation principles
  • Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
  • Highly self-motivated, self-directed.
  • Familiarity with risk management principles, regulatory requirements and, industry best practices.
  • Familiarity with Waterfall and Agile software development practices
  • Familiarity with automated testing and implementation
  • Familiarity with JIRA, Confluence, HP-ALM or other continuous integration tools
  • Flexibility to adapt to changing priorities
  • Effective with written and verbal in English communications at all levels, providing input and regulatory guidance to project teams
  • The role must maintain compliance expertise and be effective at applying requirements in the IT and business environment that supports business goals and maintaining a compliant state.

Tools/other experience:

  • AQC (HP ALM)
  • M-Files document management
  • JIRA and Confluence
  • Microsoft TEAMS
  • Agile process
  • Data Lake implementation in AWS
  • Tresata (Apache Hadoop)
  • Databricks
  • Github
Minimum Education: 
Associates degree