New Product Introduction and Technical Transfer Engineer Role
This role serves as a technical expert for new product introduction (NPI) and commercial manufacturing, participating in cross-functional teams and liaising with vendors or external groups.
Key Responsibilities:
* Develop and execute qualification/validation documentation and process development studies in line with standard approval processes.
* Implement change controls to ensure compliance with global policies and procedures.
* Contribute to continuous improvement initiatives through Lean Six Sigma methodologies.
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
* Execute equipment/qualification validation programs, including re-qualification and re-validation.
* Analyze root causes of system failures and substandard performance using standard tools and methods.
* Represent the technical engineering team in internal discussions and forums.
* Ensure compliance with global policies, procedures, guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
* Collaborate to drive a safe and compliant culture.
Requirements:
* Bachelor's Degree in Science, Engineering, or other Technical discipline.
* Experience in NPI and/or tech 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 & data systems within a GMP manufacturing environment is desirable.