This is an 11 month contract role.
The purpose of this role is to be part of the Tech transfer in Cork. The Tech transfer team is seeking a highly motivated individual who is looking for an opportunity to work in a fast-paced environment that provides a high degree of technical and project management responsibility. This work includes Ultrafiltration Diafiltration, Conjugation, Activation, data review, process performance monitoring, as well as participating in troubleshooting and technical investigations.
• Technical support of process equipment.
• Participates in change controls and other compliance related tasks.
• Participates in the review of current and future procedures
• Analyses the results of testing and determines the acceptability of results against predetermined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Identifies current and anticipated requirements for compliant computerised operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
• Coordinates with and guides other departments or outside contractors/vendors to complete tasks.
• Writing of protocols and Reports.
• Preparation and review of Qualification protocols (IQ, OQ and PQ)
• Provide technical support to manufacturing operations.
Minimum Qualifications and Experience:
• Third level qualification in Engineering or Science
• Prior experience with UFDF an advantage
• Prior experience in Tech Transfer and advantage
• Demonstrated knowledge of GDP within pharmaceutical industry
• 5 years’ experience in a pharmaceutical environment
• Strong problem-solving, collaboration, and written and oral communication skills.
• Proven ability to work independently Self-motivated and collaborate effectively as part of a team.
• Strong organizational, interpersonal, writing, and time management skills.
• Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory
• Understating of DeltaV
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