Cleaning Validation Engineer - Life Science - Cork - 12-Months+ Contract
We have a great opportunity for Cleaning Validation Engineers to join our client, a research-based biopharmaceutical company, on their journey of discovering, developing, and commercialising innovative medicines and researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19.
Responsibilities include, but are not limited to, the following:
1. Generation of Validation Impact Assessments (“VIA”)
2. Review of Change Controls
3. Generation of Process Validation Plans
4. Generation of Cleaning Validation Plan(s)
5. Update of Cleaning Validation and Process Validation documentation impacted by the changes
6. Cleaning Technical Assessment
7. Process Flow of Products/Equipment at the Company
8. Cleaning Validation Matrix
9. Generation of Process Performance Qualification (“PPQ”) and Process Validation (“PV”) Protocol(s)
10. Execution of Process Validation Protocol (PPQ/PV) activities
11. Conduct training on PPQ/PV Protocols
12. Generation of PPQ and PV Reports
13. Review/Approval of project Failure Mode Effect Analysis (“FMEA”) /Technical Assessments as required
14. Performance of cleaning validation as per Cleaning Validation Plan(s)/Protocol(s)
15. Any other ad hoc project deliverables
Requirements:
1. Relevant experience in cleaning validation
2. Knowledge of regulatory requirements and guidelines
3. Strong analytical and problem-solving skills
4. Excellent communication and training skills
If this role is of interest to you, please apply now!
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