Packaging Development Engineer
1 month ago
You will be responsible for:
• 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.
RequirementsYou will need to have:
• 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.
We would prefer for you to have:
• 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
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