uniQure

Validation Engineer - Lexington, MA

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Job

Active since 22-11-2017 Job category Engineering - Engineering
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Place in the Organization: 

The incumbent is responsible for assisting the Validation Manager in completion of all project milestones. This includes installation, operational and performance qualification of equipment and utilities, environmental qualification, process validation, and preparation of all relevant documentation to meet regulatory requirements for new and existing products (includes standard operating procedures, technical reports and risk assessments).

Key result areas (major duties, accountabilities and responsibilities):

  • Protocol generation, execution support, data analysis and report generation for various installation, operational and performance qualification activities.
  • Ensure performance of all qualification activities is in accordance with internal procedures, industry and regulatory guidance.
  • Support investigations into protocol non-conformances and site deviations.
  • Serve as initiator and owner of validation related change controls and corrective and preventative actions.
  • Review standard operating procedures related to validation practices.
  • Support the implementation of validation programs (e.g., requalification).
  • Represent the validation department at team meetings.
  • Serve as primary delegate for select validation activities.

Qualifications:

  • A minimum of a Bachelor’s degree in Life Sciences or Engineering
  • 0 – 2 years Validation experience
  • Strong communication skills (written and verbal)
  • Familiarity with Microsoft Office
  • Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
  • Ability to manage multiple activities
  • Attend meetings where required and provide subject matter expertise as applicable on the specifics of the deliverables

Core competencies:

  • The ability to communicate with employees of all experience levels from uniQure and other contract firms
  • The ability to communicate with fellow project team members
More information
This listing is a full-time job

Job category Engineering - Engineering
Industry / Industries Biotechnology
Region United States
Keywords Validation

Contact information

Name Jennifer Wagner

Location

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