Headcount is seeking a Technology Transfer Process Engineer for our multinational client’s pharma facility in Cork.
The role includes Ultrafiltration Diafiltration, Conjugation, Activation, Data Review, Process Performance Monitoring, as well as participating in troubleshooting and technical investigations.
· Technical support of process equipment.
· Participate in change controls and other compliance related tasks.
· Participate in the review of current and future procedures.
· Analyse the results of testing and determine the acceptability of results against predetermined criteria.
· Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
· Identify current and anticipated requirements for compliant computerised operations and suggest methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
· Coordinate with and guide 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.
· 5 years’ experience in a pharmaceutical environment.
· 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.
· Proven ability to work independently, be self-motivated and collaborate effectively as part of a team.
· Understanding of DeltaV