Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries in Puerto Rico, the United States, and Europe. Over 15 years, 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 Senior Engineer will join a highly technical team for a start-up manufacturing site. The Ultimate Team is in charge of the commissioning and qualification of several fully automated packaging lines for biotech drug products.
- BS in Science or Engineering
- minimum 5 years of related experience
- The Senior Engineer will provide support to the packaging engineering team and will be responsible for packaging equipment validations
- The successful candidate will also support packaging equipment project field executions, must have the availability to work in different shifts, be able to validate/qualify equipment and systems, and generate and complete validation protocols (Traceability matrix, IQ, OQ, PQ, among others).
- Must possess a solid understanding of FDA validation guidelines and industry best practices for this field and be able to 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
- Packaging validation equipment experience, (biotech drug product, pharmaceutical, medical device)
- Available to work different shifts
- Technical writing
- Willing to work overtime including weekends depending on the nature of work available
- Able to work with minimum or no supervision
- Strong interpersonal skills and must work in a team
- Basic project management and reporting skills
- Strong verbal & written communication skills in English
- Applicants must be currently authorized to work in the United States on a full-time unrestricted basis.
Ultimate Solutions is an Equal Opportunity Employer