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Validation Expert

2 weeks ago

Cork, Cork, Ireland beBee Careers Full time
Job Title: Process Validation Engineer

Job Summary:
A rewarding opportunity for a skilled Process Validation Engineer to join our team in a state-of-the-art facility.

About the Role:
This position involves performing process validation activities related to drug substance and drug products through clinical and commercial stages. Responsibilities include executing process validation protocols, generating new processes while exercising supervised judgement, and identifying solutions to meet regulatory requirements.

Main Responsibilities:
- Execute process validation activities related to drug substance and drug products
- Generate process validation protocols, execute them, and prepare final packages
- Assist with regulatory filings, answer questions from regulatory agencies, and present materials during inspections
- Develop and implement SOPs/Guideline documents with systemic improvements

Requirements:
- Experience in cGMP regulated manufacturing environment with knowledge or proficiency in process validation, process sciences, and change control
- Familiarity with project management principles
- Organisational and management skills to participate in multi-discipline project groups
- Ability to communicate with various audiences, including health authority reviewers and inspectors
- Understanding of regulatory requirements, guidelines, and recommendations for process validation expectations