A multinational company in Cork is now looking for a contract Senior Validation Engineer.
The primary purpose of this job is to support major Manufacturing Engineering Projects. The position is part of a team within the Engineering department that contributes to the overall business metrics.
Competent in validation requirements on new processes, equipment introductions & process changes.
Responsible for performing process validation studies by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
Maintains and archives all documentation pertaining to validation.
Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.
4+ years of relevant experience in a GMP environment related field and a BSc.
Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
Proficient in current Good Manufacturing Practices (GMPs).
This position will provide project leadership on continuous improvement, and risk mitigation initiatives and will also include liaison with outside suppliers and other Design & Manufacturing sites to ensure all goals and targets of the manufacturing process are achieved.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Jackson Ford on (+353) 214289628 or send your profile to email@example.com