CQV / Equipment Requalification Engineer
FRS Recruitment ·www.frsrecruitment.com
Apply directCQV / 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