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 a decade, 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.
Sr. Project Engineer
Ensures regulatory compliance by completing the appropriate documentation Responsible for the development and execution of validation & remediation projects as part of divisional strategies. Comply with all regulatory and quality systems standard requirements. Performance of validation gap assessment & analysis, validation master plans, and validation protocols (generation/execution/reports) such as IQ/OQ/PQ/PPQ/Decommissioning for existent and new products. Performance of different kinds of validations, such as process & equipment validations, software validation, test method, and inspection method validations. Performance of confirmation runs and product build ups at manufacturing as part of divisional projects requirements. Prepares, reviews, and analyzes appropriate regulatory documentation. Continuous interaction with divisional project leaders to support their activities at site level.
Bachelor’s degree in Engineering related field with 6+ years or more of experience with Validation and Project Engineering.
REQUIREMENTS & SKILLS
Ultimate Solutions Corp is an Equal Opportunity Employer.
- Experience in Process Validation
- Strong experience in qualification activities (IQ OQ PQ PPQ TMV IMV) documentation generation/execution/closing for existent and new product introduction
- Quality System knowledge.
- Experience managing projects – planning/organization/presentations
- Technical writing experience (in English)
- Flexibility to work on weekends as required
- Experience working with MS Office programs (Word, Excel, Project, Power Point
- Process development experience or good technical knowledge.
- Medical Devices documentation experience (FMEAs, change management, MES, etc)
- Proven ability to work within a regulated industry environment and with a track record of
- Effective communication skills required due to support of cross functional projects within a team.
- Project Management
- Problem Solver
- Fully Bilingual (verbal and written)