Job Opportunity: NPI/Tech Transfer Engineer
We are seeking a skilled Process Engineer with experience in New Product Introduction (NPI) and Technical Transfer to join our team. As an NPI/Tech Transfer Engineer, you will be responsible for supporting the introduction of new products into commercial manufacturing while ensuring compliance with regulatory requirements.
The ideal candidate will have a strong background in process engineering, including experience with equipment and process validation, sterile filling processes, and automation systems. Additionally, they will possess excellent communication and collaboration skills, with the ability to work effectively within cross-functional teams.
Responsibilities:
* Design, author, review, and approve qualification/validation documentation and process development studies.
* Develop and execute change controls.
* Contribute to Kaizen events and support continuous improvement initiatives.
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
* Execute equipment/qualification validation programs, including re-qualification and re-validation.
* Support the implementation of Lean Six Sigma methodologies to drive process improvements.
* Analyze system failures and substandard performance using standard tools and methods to resolve issues.
* Represent the Operations Carlow team at global technical forums and participate in internal technical group discussions.
* Ensure compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
Requirements:
* Bachelor's degree in Science, Engineering, or a related technical discipline.
* Experience in New Product Introduction and/or Technical Transfer.
* At least 3 years of experience in GMP settings.
* Equipment and process validation experience.
* Sterile filling processes and equipment experience.
* Familiarity with process monitoring systems, automation systems, operational intelligence, and data systems within a GMP manufacturing environment is desirable.