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Validation Process Engineer
2 weeks ago
Job Description:
Process Validation EngineerWe are seeking an experienced Process Validation Engineer to join our team in Cork, Ireland. The successful candidate will be responsible for performing process validation activities related to drug substance and drug products.
Key Responsibilities:- Develop and execute process validation protocols
- Implement process changes and new processes while ensuring compliance with regulatory requirements
- Assist with preparation of regulatory filings and answer questions from regulatory agencies
- Develop and implement SOPs/Guideline documents with systemic procedural improvements
- Gain/maintain knowledge of industry standards and regulatory requirements
- Experience in a cGMP regulated manufacturing environment
- Knowledge of process validation, process sciences and change control
- Organisational and management skills to participate in multi-discipline project groups
- Ability to communicate complex scientific/technical information
- Understanding of regulatory requirements, guidelines and recommendations for process validation expectations
