Cleaning Validation Engineer

Summary:
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.

Responsibilities:

• 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.