CQV / Equipment Requalification Engineer

Location: Waterford
Contract: Contract

About the Role

We are currently recruiting for a CQV / Equipment Requalification Engineer to support a leading pharmaceutical company with equipment requalification and GMP remediation activities.

This is an excellent opportunity for an experienced CQV, Validation or Qualification Engineer with a strong background in a GMP manufacturing environment.

The successful candidate will work closely with Engineering and Quality teams to assess, implement and execute equipment requalification remediation activities.

Key Responsibilities

• Assess equipment requalification and remediation requirements.
• Support the implementation of a harmonised requalification methodology and categorisation.
• Execute equipment requalification and remediation activities.
• Prepare and review requalification and qualification documentation.
• Support IQ/OQ/PQ activities.
• Support deviations, CAPA and process confirmation activities.
• Monitor KPIs and progress within the assigned scope.
• Collaborate closely with local Engineering and Quality teams.
• Identify and support the resolution of qualification gaps and compliance issues.
• Ensure activities are completed in accordance with GMP and validation requirements.

Required Experience & Skills

• Previous experience in equipment requalification within a GMP manufacturing environment.
• Strong knowledge of CQV and IQ/OQ/PQ.
• Experience with GMP validation and remediation.
• Experience with engineering, utilities, facilities, process equipment and commissioning/qualification.
• Experience supporting or managing deviations and CAPA.
• Strong technical documentation and problem-solving skills.
• Ability to work effectively with Engineering, Quality and cross-functional teams.

What This Opportunity Offers

This is a strong opportunity for a CQV / Validation / Qualification Engineer to work on a significant equipment requalification and GMP remediation programme within a leading pharmaceutical environment.

If you have experience in CQV, equipment qualification, validation or GMP remediation and are interested in this opportunity, please get in touch