
MS&T Engineer/ Associate Scientist/ Scientist
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MS&T Associate Scientist/ Scientist
Author and execute technology transfer and validation documentation, including protocols, risk assessments, summary reports, and related lifecycle documentation
Oversee process validation strategies including process qualification, continued process verification, and lifecycle management activities.
Perform technology transfer and validation activities in alignment with project schedules and site procedures.
Support optimization, characterization, and scale-up of radiopharmaceutical manufacturing processes.
Create, review, and revise related documents, including SOPs, validation plans, master plans, and protocols.
Lead and coordinate execution of validation and technology transfer activities
Lead periodic review activities for validated systems
Support change control through technology transfer, validation, and other required actions
Partner cross-functionally with internal departments, and external vendors to ensure compliant execution of technology and validation activities
Lead small to mid-sized projects and provide support for larger projects
Support manufacturing process readiness and train personnel in aseptic principles, manufacturing processes, and other programs as required.
Support regulatory inspections by the FDA, EMA, and other healthy authorities
Bachelor’s degree in Life Science, Engineering, or a related field
5+ years of relevant technology transfer or validation experience in a GMP-regulated environment
3+ years of experience with GMP aseptic manufacturing processes
Hands-on experience with process validation and lifecycle validation practices
Familiarity with risk-based validation principles and good documentation practices
Ability to work safely in a manufacturing environment
Strong organizational skills, attention to detail, and a practical, solution-oriented approach
Strong communication skills with the ability to clearly summarize technical topics for cross-functional audiences
Experience with digital validation platforms such as ValKit or Kneat
Experience supporting technology transfer and validation during facility startup or expansion
Experience in radiopharmaceutical, pharmaceutical, biotech, or other highly regulated manufacturing operations
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Originally posted by Ratio Therapeutics, Inc.. View original posting
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