- Validation Specialist (Temperature Mapping Project)
- Improves inspection processes, technologies and systems to ensure compliance with drug quality and cost specifications.
- Writes test procedures, inspection machinery specifications, performs line trials and troubleshooting, works with inspection technology machinery vendors, 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.
- Ensures that equipment's are capable of handling all current products configuration components and will determine whether it can support proposed changes.
- Supports, assists and /or justifies inspection technology/operations capital projects help research.
- Justifies, designs, specifies, purchases, tests, installs and validates any new equipment purchases.
- Plans, coordinates, and executes projects to assure achievement of site's departmental and company goals and objectives. Manage project timetables for new and ongoing projects. Provide project status through the use of project plans, presentations, or written reports.
- Provides troubleshooting inspection equipment, executing equipment trials and systems with the knowledge to modify and recommend changes to equipment's and components as needed.
- 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.
- 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, especially 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. START YOUR APPLICATION
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MV01-041624 Sr. Parenteral Inspection Technology Specialist - Manatí, Puerto Rico - Validation & Engineering Group, Inc
Descripción
Department: Field - BE Location: Manati, 091START YOUR APPLICATION
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Responsibilities:
Minimum Requirements:
