Sr Validation Lead/Virtual Job Fair MAY 2025 id-11240
Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For 20 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 Senior Validation Lead will join a highly technical team that will manage the technical characterization aspect of each line. Will have experience characterizing and optimizing packaging equipment recipes parameters of different vendors. The Senior Validation Lead will manage the rest of the team working in the line with Ultimate Solutions management as liaison with client to guarantee service client quality. Will report and be in direct communication with the PM and C&Q Lead to maintain the entire project quality, finance and schedule. This opportunity will be on-site and will require to relocate in the United States.
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Responsibilities:
- Manage the technical aspect of each line, provide support to the packaging engineering team and be responsible for packaging equipment characterization activities.
- Manage the rest of the team working in the line, leading the team to the successful execution of characterization activities.
- Communicate with the PM to maintain the entire project metrics.
- Must possess a solid understanding of FDA validation guidelines and industry best practices for this field and be able to implement packaging validation/characterization standards on a daily basis.
- Assure that policies and procedures are implemented to validate/qualify/characterize 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
Requirements/Skills:
- BS Science or Engineering
- Minimum of 6 years of related experience
- Packaging/Characterization validation equipment experience, (biotech drug product, pharmaceutical, medical device) of different vendors and preferably will have experience working in any of the client's sites worldwide.
- Strong leadership and people management skills
- Technical writing
- Availability to work in different shifts, extended shifts and weekends as required. Must also be able to travel out-of-state in short notice.
- 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
- Must possess the ability to multi-task.
- Must possess the ability to work under pressure.
- Ability to understand complex problems and to collaborate and explore alternative solutions.
- Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
- Ability to compose letters, outlines, and basic reports and/or to orally communicate technical information.
- 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 USA, LLC is an equal opportunity employer. The company prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
