Jr Validation Engineer

Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over 2 decades, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.

The Jr Validation Engineer will join a highly technical team for start-up and continued commercial production activities in a manufacturing site. The USA Ultimate Team is in charge of the commissioning and qualification of several fully automated packaging lines for biotech drug products.

• Provide support to the packaging engineering team and responsible for packaging equipment validations.
• Support packaging equipment project field executions.
• Implement packaging validation standards on a daily basis.
• Implement policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
• Generate, execute, review, and complete regulatory documentation.
• Communicate with the staff and management on ways of implementing plans and recommendations.
• Assure project deliverables are done in a timely manner.
• Travel US & International up to 25%
• On-site job in Columbus, Ohio

• BS in Science or Engineering
• Minimum 2 years of related experience
• Packaging equipment validation experience, (biotech drug product, pharmaceutical, medical device)
• Experience in packaging equipment such as:

• Assembly Machine
• Labeler
• Buffer Conveyor
• Carton Labeler
• Case Packer

• Must have the availability to work in different shifts, work overtime; including weekends as required.
• Must possess a solid understanding of FDA validation guidelines and industry best practices for this field.
• Ability to validate/qualify equipment and systems, and generate and complete validation protocols (Traceability matrix, IQ, OQ, PQ, among others).
• Technical writing
• Basic project management and reporting skills
• Able to work with minimum or no supervision
• Strong interpersonal skills and must work in a team
• Applicants must be currently authorized to work for any employer in the United States on a full-time unrestricted basis. Employment visa sponsorship is not available.
• Not open for Corp-to-Corp arrangements.

Ultimate Solutions is an Equal Opportunity Employer