Senior Specialist, Engineering - Oral Solid Dose Packaging
$117,000–$184,200 year
On-siteWilson, North Carolina, United States
Job Summary
Lead technical projects for packaging and medical device equipment at the Manufacturing Division-Wilson, including scale-up, technology transfer, and process validation for bottle/blister and autoinjector lines. Manage capital and expense projects for new equipment installation and qualification while providing root cause analysis for complex quality events. Conduct literature reviews and experiments to justify process changes, author packaging process descriptions, and support regulatory activities such as site inspections and FDA observations. Lead project sub-teams and provide training to others with minimal supervision, ensuring all activities adhere to GMP, Lean Six Sigma, and site safety protocols.
Required Qualifications
- Bachelor's degree in Engineering, Industry Technology
- Minimum of 5 years relevant industrial experience
- Experience in Bottle/oral solid dosage form packaging
- Experience working in a GMP Pharmaceutical Environment
- Demonstrated leadership and teamwork skills
- Excellent analytical ability
- Proven communication skills
- Strong oral and written communication skills
- The ability to work under limited supervision
- Mechanical aptitude to troubleshoot/resolve equipment issues
- Expertise in qualification and process validation practices for complex systems
- Experience in equipment installation and qualification for complex systems
- Experience in Device Packaging
- Good Manufacturing Practices (GMP)
- Lean Six Sigma (LSS)
- Oral Solid Dosage
- Packaging Engineering
- Pharmaceutical Packaging
- Regulatory Compliance
- Valid Driving License
Desired Qualifications
- Experience in Autoinjector assembly and packaging
- Project management skills
- Experience in equipment qualification activities
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