CQV Engineer – Ref. MQ811

Website HeadcountGroup Headcount Solutions

CQV Engineer

Headcount Solutions is seeking a CQV Engineer for our client’s biologics facility. This is a contract role (minimum 12 months) where the person will be responsible for the authoring and execution of the Performance Qualification (PQ) documents on site equipment and utilities including HVACs, Downflow Booths, Autoclaves, CTUs, Gases and Steam.  The role is a combination of hands-on execution in the field and validation SME support for the project.

Main Responsibilities:

  • Plan and co-ordinate the performance qualification (PQ) activities for equipment and utilities in the project ensuring all projects are on schedule and meet the set timelines.
  • Effectively monitor and communicate the performance qualification activities and execution plan to other teams, project managers and key stakeholders.
  • Author, review and execute PQ protocols in line with Quality and Regulatory expectations.
  • Author PQ reports in line with Quality and Regulatory expectations.
  • Co-ordinate the day-to-day management of contractors where qualification activities are outsourced e.g. Temperature Mapping, HVAC qualification, Gas qualification, Autoclave qualification etc.
  • Manage performance qualification documentation, test scripts, qualification protocols, summary reports and risk assessments.
  • Perform validation SME reviews of vendor protocols.
  • Provide validation SME support for risk assessments and change controls.
  • Support the development of Standard Operating Procedures.

Requirements:

  • Level 8 degree in a Science, Engineering or other related technical discipline.
  • 3+ years’ experience in a similar role.
  • Experience developing validation documentation.
  • Experience executing validation protocols.
  • Experience closing out validation activities and writing validation reports.
  • Project management experience a plus.
  • Ability to analyse data and make recommendations.
  • Experience in working with cross functional teams.
  • Excellent report, standards, technical writing skills.

For further information, please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

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