A leading biopharmaceutical company is seeking a NPI Process Engineer to support new product introductions into a GMP sterile fill-finish facility.
Key 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.
Required Skills and Qualifications
* 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 products.
* Hands-on involvement in technical transfer projects.
* Familiarity with single-use technology in manufacturing.
Desirable Requirements
* 3+ years' experience in biologics or sterile manufacturing.
* Experience preparing or executing validation protocols.
* Understanding of cGMP batch record requirements and QA systems.