Validation Engineer - #308211

About Ratio Therapeutics

Ratio Therapeutics is committed to improving and extending the lives of cancer patients without sacrificing their quality of life. We are a team of passionate scientists, engineers, and business professionals dedicated to advancing the field of targeted radioligand therapy. To accomplish this, we utilize our proprietary TRILLIUM and MACROPA platforms: TRILLIUM allows fine-tuning of radioligand pharmacokinetics thereby enhancing the therapeutic index, while MACROPA simplifies the manufacturing process for the alpha-emitting isotope, actinium-225. These enabling platform technologies have resulted in an emergent pipeline of novel therapeutic candidates. We are looking for talented, dedicated, and creative individuals eager to help us advance these technologies from discovery research through clinical development. Join us in our quest to become the leading innovator in radioligand therapy and improve the lives of cancer patients and their families.

About The Position

Ratio is seeking a Validation Engineer to support the buildout and phased expansion of our new radiopharmaceutical manufacturing facility in the Salt Lake City metropolitan area (West Valley City, Utah) and to support GMP manufacturing operations once the site is operational. The ideal candidate will enjoy working in a collaborative, fast-paced, multidisciplinary environment. Initially, this role will focus on construction, commissioning, and qualification activities with emphasis on facility, utility, and equipment qualification (IQ/OQ/PQ). Over time, the Validation Engineer will support ongoing lifecycle validation, periodic review of validated systems, change control impact assessments, and validation support for new projects and equipment introductions.

Key Responsibilities

• Author and execute validation documentation, including URS, risk assessments, IQ/OQ/PQ protocols, summary reports, and related lifecycle documentation
• Perform commissioning, qualification, and validation activities in alignment with project schedules and site procedures
• Create, review, and revise qualification-related documents, including SOPs, validation plans, master plans, and execution plans
• Lead or support design reviews, factory acceptance testing (FAT), commissioning, and qualification activities
• Lead periodic review activities for validated systems and equipment
• Support change control through validation and other required actions
• Partner cross-functionally with internal departments , and external vendors to ensure compliant execution of CQV activities
• Lead small to mid-sized capital projects and provide validation support for larger projects
• Participate in quality systems activities, including change controls, CAPAs, deviations, and investigations
  
  

Required Qualifications

• Bachelor’s degree in Engineering or a related technical field
• 5+ years of relevant validation or qualification experience in a GMP-regulated environment
• Hands-on experience with equipment, utility, or facility qualification 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
• Comfortable operating in a fast-paced environment with both strategic and hands-on responsibilities
  
  

Preferred Qualifications

• Experience with digital validation platforms such as ValKit or Kneat
• Experience supporting commissioning and qualification during facility startup or expansion
• Knowledge of aseptic manufacturing environments strongly preferred
• Experience in radiopharmaceutical, pharmaceutical, biotech, or other highly regulated manufacturing operations
• Experience supporting change control, deviations, and validation impact assessments
  
  

The annual base salary for this role is expected to range between $90,000 and $120,000. This range is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. The actual base salary offered will depend on a variety of factors, including qualifications, work experience, skills, level of education attained, certifications or other professional licenses held, the location in which the applicant lives and/or from which they will be performing the job, and other job-related factors permitted by law.