Packaging Engineer
Tandem Project Management
- Dublin
- Contract
- Full-time
Our client is a global pharmaceutical company looking for a Packaging Engineer who will be responsible for providing technical and/or engineering support for Finished Product (FP) manufacturing, providing packaging engineering support through all phases of the commercial finished product lifecycle, including technology transfer, validation, and routine FP commercial manufacturing. This involves providing technical support to manufacturing operations at contract manufacturing organisations (CMOs) used as client pack sites. The position requires effective cross-functional collaboration with external contractors and internal partners including internal FP subject matter experts, New Product Introduction (NPI), Internal/External Manufacturing Operations, Quality, Marketing and Regulatory partners.Responsibilities:
- Providing technical support to biologics, small molecule and combination medical device product packaging development at CMOs.
- Support troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners.
- Ownership and management of Change Controls and Risk Assessments executed in support of Packaging Development activities.
- Technical writing of Packaging Tech Transfer Protocols, Packaging Technical Studies and User Requirements Specifications as applied to Packaging Tech Transfers and Launches.
- Collection, organisation, trending, and analysis of Packaging Development data.
- Provide input and other technical documents for regulatory agency submission in support of FP manufacturing processes at internal/external FP manufacturing sites.
- Bachelors degree in engineering preferred (or similar technical qualification / equivalent experience in pharma or medical device packaging development).
- Understanding of cGMP requirements for biopharmaceutical manufacturing.
- Exposure to Project Management principles and tools is preferable.
- Experience of MS Project or other project management software is preferable.
- Exposure/experience of Risk Assessment in a cGMP environment is preferable.