The successful candidate 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 life cycle, including technology transfer, validation, and routine FP commercial manufacturing. 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
Requirements:
- Bachelor's 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
- Organised analytical thinker with strong attention to detail
Job Title: Packaging Development Engineer
Location: Dublin, Ireland
Job Type: Contract
Trading as Aerotek. Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom. No. 2876353. Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice.
To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to the website.
We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.
Posted Date: 11 Apr 2024
Reference: JSJP-004422272
Employment Business: Actalent
Contact: Nathan Carnegie