Sr. Parenteral Inspection Technology Specialist
Flexible & Integrated Technical Services, LLC
- Manatí, PR
- Permanent
- Full-time
- Bachelor’s degree in Science or Engineering (Mechanical, Electrical or Computer) & five (5) years of exposure in the Pharmaceutical industry.
- Fully bilingual (Spanish and English)
- Project Management Skills
- Experience in:
- Parenteral Inspection and Packaging processes
- Technical Writing (protocols, assessments, CAPAs, etc.)
- Inspection/Packaging Technology experience (plus)
- Project Management.
- cGMP's, OSHA and FDA Regulations.
- If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!
- Improve inspection processes, technologies, and systems to ensure compliance with drug quality and cost specifications.
- Write test procedures, inspection machinery specifications, performs line trials and troubleshooting, work with inspection technology machinery vendors, etc.
- Coordinate inspection process validation and line trial activities with local validation, production, engineering, planning and quality groups as needed.
- Support new inspection technology and product transfers.
- Ensure that equipment can handle all current products configuration components and will determine whether it can support proposed changes.
- Justify, design, specify, purchase, test, install and validate any new equipment purchases.
- Manage project timetables for new and ongoing projects.
- Provide project status using project plans, presentations, or written reports.
- Provide assistance and technical support to inspection projects for products manufactured at the pharmaceutical manufacturing site.
- Oversight and support the overall inspection certification program, personnel certification, new inspection methodology, inspection test set maintenance and control.