A global biopharmaceutical company in Cork is looking to hire a Cleaning Validation Engineer. The successful candidate will be responsible for supporting the cleaning program on site.
- Responsible for ensuring that the Manufacturing Process Transfers project tasks and cleaning tasks are completed on time.
- Generation of Validation Impact Assessments (“VIA”).
- Review of Change Controls.
- Generation of Process Validation Plans.
- Generation of Cleaning Validation Plan(s).
- Update of Cleaning Validation and Process Validation documentation impacted by the changes.
- Cleaning Technical Assessment.
- Process Flow of Products/Equipment.
- Cleaning Validation Matrix.
- Generation of Process Performance Qualification (“PPQ”) and Process Validation (“PV”) Protocol(s).
- Execution of Process Validation Protocol (PPQ/PV) activities.
- Conduct training on PPQ/PV Protocols.
- Generation of PPQ and PV Reports.
- Review/Approval of project Failure Mode Effect Analysis (“FMEA”) /Technical Assessments as required.
- Performance of cleaning validation as per Cleaning Validation Plan(s)/Protocol(s).
- Any other ad hoc project deliverables.
Qualifications & Experience:
- Minimum – BSc in either Engineering or Science
- 5 years’ experience supporting a pharmaceutical / biopharmaceutical manufacturing site.
- Previous experience in cleaning validation would be an advantage.
- Knowledge of qualification/validation requirements and good documentation practices.
To apply for this job email your details to firstname.lastname@example.org.