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.
DESCRIPTION
The engineer will manage the technical aspect of each line. Will have experience validating packaging equipment (including thermoforming) of different vendors and preferably will have experience working in any of the Amgen sites worldwide.
He will manage the rest of the team working in the line. Will also be in communication with the PM to maintain the entire project metrics.
EDUCATION
- BS in Science or Engineering
- Minimum 5 years of related experience
RESPONSIBILITIES
- The engineer will provide support to the packaging engineering team and will be responsible for packaging equipment validations.
- Will lead the team to successful execution of validation activities.
- 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
- Assure that policies and procedures are implemented to validate / qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
- Review, complete and approve 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
REQUIREMENTS / SKILLS
- Packaging validation equipment experience, (biotech drug product, pharmaceutical, medical device)
- Strong leadership and people management skills
- 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 and teamwork skills
- Advanced project management and reporting skills
- Strong verbal & written communication skills in English
- 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
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