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US

Process Development Scientist

Ultimate Solutions
šŸ‡µšŸ‡· Puerto Rico
Staff / Principal
5 months ago
  • Regulatory Compliance
5 months ago
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Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For over 20 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to global leaders in the pharmaceutical, biotechnology, medical device, and logistics sectors.
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DESCRIPTION
The Process Development Scientist conceives, designs, implements and executes specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.Ā Ā 

RESPONSIBILITIES
  • Conceives and designs, executes or evaluates, and interprets experimental strategies.
  • Provides input to new processes to generate robust and reliable data.
  • Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
  • Designs, monitors or conducts experimental strategies with general guidance from supervisor.
  • Provides data analysis and interpretation, and assesses impact of the data on the project.
  • Keeps current in field of scientific expertise and areas relevant to their function.
  • Monitors field of expertise, including literature and technology development, and communicates relevant observations.
  • May introduce advanced scientific methods.
  • Develops and implements new and novel protocols to address specific issues.
  • May represent the department on project teams under supervision of a senior scientific staff member.
  • May initiate productive collaborations within and outside of the department or company.
  • Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
  • Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
  • Participates in external scientific community.
  • May assume lead role in department-wide support efforts such as safety, recruiting and committees.
  • May develop supervisory and mentoring skills.
  • Develops and follows timelines for completing project team work.
EDUCATION
  • Doctorate OR
  • Master + 2 years of Scientific experience OR
  • -Bachelors + 4 years of Scientific experience.
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REQUIREMENTSĀ 
  • Experience in Regulated Industry
  • Ā Proficient in creating and executing validation and qualification documentation
  • Provide support to vision inspection qualification and characterizations
  • Requires excellent communication skills with suppliers and other sites
  • A Plus: Knowledge in automated vision inspection systems
  • A Plus: Knowledgeable in CSV. Support CQV documentation and execution
    Other Considerations:
  • Willing to work during regular business hours, night shift, and/or weekends, as needed to meet the projectsā€™ schedule.
āš ļøĀ Employment visa sponsorship is not available.
āš ļøĀ Not open for Corp-to-Corp arrangements.

Ultimate Solutions Corp is an Equal Opportunity Employer

Process Development Scientist Ā· Ultimate Solutions

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