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Process Validation Specialist (Packaging)

Dorado, PR
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.

Process Validation Specialist
RESPONSIBILITIES
  • Assesses process capabilities, prioritizes process improvement opportunities, and implements on multiple and moderately complex processes.
  • Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
  • Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
  • Prepares and presents technical data and recommendations at technical reviews.
  • Writes validation protocols and reports applicable to new processes.
  • Ensures proper documentation is completed to meet quality systems requirements.
  • Oversees development builds associated with the project using special work requests.
  • May serve as a core team lead or extended team member on new development projects.
  • Possibly supervise and/or mentor engineers with the team.

EDUCATION
Bachelor’s degree in Engineering or related field education with 3-5 years or more of experience in the Regulatory industry.
 
REQUIREMENTS & SKILLS 
  • Demonstrated use of  DFSS tools (DOE, problem solving)
  • Minimum of 5+ years of demonstrated process development / improvement activities.
  • Demonstrated field experience with Automation/Vision Systems and packaging validation.
  • Highly motivated individual that can independently drive deliverables to completion through collaboration among team members.
  • Demonstrated ability to develop and drive innovative solutions into processes and products.
  • Medical Device Design experience; new product development
  • Equipment validations and process characterization
  • Demonstrated cross functional teamwork in technically demanding environment
  • Demonstrated ability to develop processes from concept to production
  • Open to occasional travel
  • GMP & ISO knowledge, understanding and experience
  • Proficient in MS Word, PowerPoint, Excel, and Project
  • Effective interactions in a team environment
  • Team player, self-starter, persistent, tactful, and persuasive
  • Good organizational skills, detail-oriented & accurate, analytical skills
  • Effective verbal and written communication skills (writing and presentations)
  • Fully Bilingual (English and Spanish)
  • Able to work with minimum or no supervision 

Ultimate Solutions Corp is an equal opportunity employer.

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Process Engineer
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Validation Engineer/Specialist

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