Responsible of providing support to the inspection engineering activities related to new inspection technologies development, inspection product transfer and inspection operational support of Sterile/Biologics products. Responsibilities include the Interaction and support using the company standard inspection technology documentation change control system. This position must comply with all security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
Responsibilities- Improves inspection processes, technologies and systems to insure compliance with drug quality and cost specifications.
- Writes test procedures, inspection machinery specifications, performs line trials and trouble shooting, etc.
- Coordinates inspection process validation and line trial activities with local validation, production, engineering, planning and quality groups as needed.
- Supports new inspection technology and product transfers.
- Supports and assess current inspection processes; perform improvement or changes to existing inspection technology processes.
- Plans, coordinates, and executes projects to assure achievement of site's departmental and company goals and objectives.
- Manage project timetables for new and on going projects. Provide project status through the use of project plans, presentations, or written reports.
- Provides troubleshooting inspection equipment, executing equipment trials and systems
- Provides 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.
Qualifications- Bachelor Degree in Sciences or Engineering ( Mechanical, Electrical or Computer)
- Five (5) years in the Pharmaceutical Industry (Parenteral Manufacturing/Packaging Operations)
- Strong background on Parenteral Inspection and Packaging processes is required with device assembly experience preferred.
- Understanding of a broad spectrum of packaging materials, structures, components, and related conversion processes, specially packaging components for sterile products.
- Excellent technical writing/oral communication skills (English/Spanish).
- Flexible to work extended hours when required.
- Computer Proficiency: MS Office, MS Project, AutoCad.
- Able to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the project execution.
- Technical knowledge in pharmaceutical manufacturing processes, technologies and processing equipment - Sterile Packaging, Inspection and Processes.
- Capability for providing hands-on support for equipment, materials and process troubleshooting.
- Knowledge of process improvement and troubleshooting.
- Time management, planning and organization capabilities.
- Project management skills.
- Leadership and teamwork skills.
- Knowledge of cGMP's, OSHA and FDA Regulations.
- Problem-solving skills.
