Description
Role - Packaging Validation Engineer (Serialisation)Type - start asap until end of 2015
Location - Dublin, Ireland
The Role:
• Support the project management of ongoing serialisation implementations
• Provide assistance, guidance and technical support in order to support implementation activities, as deemed necessary by Serialisation Lead
• Collaborate with Serialisation Lead, Technical Group, Production Group and Quality Representatives to ensure proper status communication, risk escalation, and update on progress during execution
• Attend and or conduct regular meetings to provide project updates to Serialisation Lead regarding progress toward milestones
• Work with equipment vendors, develop or identify internal SOPs impacted by serialisation; revise and develop new documents as necessary. Provide standardised training materials for processes changes for purposes of commercial cutover to serialised product.
• Support continuous improvement for the processes developed for serialization
Requirements:
• Relevant experience in the pharmaceutical, biopharmaceutical or related industry
• Bachelor’s degree in engineering, chemistry, pharmacy or related sciences.
• Validation in packaging is a minimum.
• Serialisation experience is a huge advantage
• Operations experience in pharmaceutical manufacturing to cGMP standards
• Extensive knowledge of regulatory guidelines and validation practices and an ability to effectively transfer complex knowledge regarding science and engineering procedure is essential for the role.
• Demonstrated financial and project management skills and success in negotiating complex supply and toll manufacturing agreements with external suppliers is also desired.