Overview
Responsible for supporting new product introductions (NPI) into a GMP sterile fill-finish biologics facility, including technical transfer, process readiness, and manufacturing support.
12 month fixed term role.
Core Responsibilities
- Conduct gap analyses, cleaning assessments, and facility fit studies for new product introductions
- Execute technical transfer deliverables including process documentation, risk assessments, and validation support
- Monitor and analyse manufacturing data during DP campaigns
- Support development and optimisation of DP fill-finish processes
- Lead or support development of NPI documentation (transfer protocols, batch records, SOPs)
- Prepare and maintain material and consumable specifications
- Interface with global tech transfer teams on product introduction projects
- Ensure compliance with GMP, HPRA/FDA, and EHS requirements
- Provide on-floor technical support during NPI execution
Essential Requirements
- Degree in Engineering, Science, or related technical discipline
- Minimum 1 year experience in GMP pharmaceutical or biopharma environment
- Experience with DP fill-finish operations
- Experience with lyophilised (LYO) products
- Hands-on involvement in technical transfer projects
- Familiarity with single-use technology in manufacturing
Desirable
- 3+ years’ experience in biologics or sterile manufacturing
- Experience preparing or executing validation protocols
- Understanding of cGMP batch record requirements and QA systems
For more details on this role, feel free to reach out to Emma Cawley at emma.cawley@collinsmcnicholas.ie.
Kindly note that, given the expected high volume of applications, we can only respond to candidates whose qualifications closely match the specific requirements of the role. We genuinely value your interest in this opportunity and thank you for your understanding.