Packaging Development Engineer
Adaptive HVM
- Southside Dublin
- Permanent
- Full-time
- 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.
- Strong communication ability to present and influence.
- Organized analytical thinker with strong attention to detail.
- Excellent oral and written communication skills, including technical writing.
- MS Excel, MS Word, MS Powerpoint proficiency
- Experience of using systems within a GMP environment such as Change Control and Document Management systems.
- Exposure to Project Management principles and tools.
- Experience of MS Project or other project management software.
- Exposure/experience of Risk Assessment in a cGMP environment