NPI Process Specialist
4 days ago
Job Overview:
The New Product Introduction (NPI) Process Engineer plays a vital role in ensuring seamless transitions of new products into commercial manufacturing. This position requires collaboration with cross-functional teams to deliver technical support and expertise.
Responsibilities:
- Process Development: Design, execute, and validate qualification/validation documentation for process development studies.
- Change Control: Develop and implement effective change controls to maintain compliance.
- Kaizen Events: Contribute to continuous improvement initiatives through Lean Six Sigma methodologies.
- Investigations: Author and review comprehensive investigations to drive root cause analysis.
- Equipment Qualification: Execute equipment/qualification validation programs to ensure optimal performance.
- Technical Representation: Serve as a technical representative in internal discussions and global forums to promote safe and compliant practices.
Requirements:
- Bachelor's Degree: In Science, Engineering, or Technical discipline.
- Experience: 3+ years in GMP settings, with experience in new product introduction and/or tech transfer.
- Validation Expertise: Equipment and process validation experience is essential.
- Sterile Filling Processes: Familiarity with sterile filling processes and equipment is desirable.
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