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 for talented, dedicated individuals who are committed to work under the highest standards of ethics to and with expertise in the following area:

• Packaging Technology Specialist

Responsibilities:

• Responsible of providing support to the packaging engineering activities related to new package development, packaging product transfer and packaging operational support of Sterile/Biologics products.
• Responsibilities include the Interaction and support using the standard packaging 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.
• Improves packaging processes, technologies and systems to insure compliance with drug quality and cost specifications.
• Writes test procedures, packaging machinery specifications, performs line trials and trouble shooting, works with packaging machinery vendors, etc.
• Develops reviews and approves packaging Bills of Materials, labels, component specifications.
• Coordinates packaging validation and line trial activities with local validation, production, engineering, planning and quality groups as needed.
• Supports new packaging technology and product transfers.
• Supports and assess current packaging processes; perform improvement or changes to existing packages and packaging processes.
• Ensures that equipments are capable of handling all current packaging components and will determine whether it can support proposed changes in packaging components.
• Supports, assists and /or justifies packaging 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 on going projects.
• Provide project status through the use of project plans, presentations, or written reports.
• Provides troubleshooting packaging equipment, executing packaging equipment trials and systems with the knowledge to modify and recommend changes to equipments and components as needed.
• Provides assistance and technical support to packaging projects for products manufactured at the pharmaceutical manufacturing site in Puerto Rico.
• The support includes equipment used in the packaging of Oral solid products with more emphasis on Parenteral packaging.
• Reviews and approves component specifications in compliance with applicable regulations and the internal policies and procedures.

Requirements:

• Bachelor Degree in Sciences or Engineering ( Mechanical, Electrical or Computer)
• Five (5) years in the Pharmaceutical Industry (Packaging Operations/Parenteral Manufacturing)
• Strong background on Parenteral Packaging and Inspection 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