NPI Technical Specialist
Job Summary:
We are seeking a skilled professional to support the biopharmaceutical industry in Carlow. The successful candidate will serve as technical support for new product introduction (NPI) and commercial manufacturing, participating in cross-functional or single-function teams.
About the Role:
* Develop qualification/validation documentation and process development studies in line with standard approval processes.
* Implement change controls to improve processes and ensure compliance.
* Contribute to continuous improvement initiatives.
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
* Execute equipment/qualification validation programs.
* Support methodologies to drive continuous improvement.
* Analyze system failures and substandard performance using standard tools and methods to resolve machine and system issues.
* Represent the technical operations team in internal discussions and global forums.
* Ensure compliance with regulatory requirements and current Good Manufacturing Practices (cGMP).
* Collaborate to drive a safe and compliant culture.
* Perform other duties as assigned.
Requirements:
* Bachelor's Degree in Science, Engineering, or other Technical discipline.
* New product introduction and/or tech transfer experience.
* 3+ years of experience in a GMP setting.
* Equipment and process validation experience.
* Sterile filling processes and equipment experience.
* Familiarity with process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment is desirable.