Radiopharmaceutical Facilities and Validation Engineer presso Ratio Therapeutics, Inc.

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 highly motivated and detail-oriented Radiopharmaceutical Facilities and Validation Engineer to join our team as a foundational member at our new, state-of-the-art radiopharmaceutical manufacturing facility in Salt Lake City. This critical role is responsible for ensuring all facility systems, utilities, and equipment are commissioned, qualified, and validated according to strict regulatory standards, including Good Manufacturing Practices (GMP). In addition, this position will lead all aspects of routine and non-routine facility and equipment maintenance, ensuring operational readiness and compliance. The ideal candidate will have a strong background in the pharmaceutical or biotechnology industry, with a focus on Commissioning, Qualification, and Validation (CVC) processes and facility management.

Key Responsibilities

• Lead and execute commissioning, qualification, and validation activities for a new radiopharmaceutical manufacturing facility, including cleanrooms, HVAC systems, water systems (WFI, RO), and compressed gases.
• Develop, author, and review validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for facility systems, utilities, and equipment.
• Develop and implement a comprehensive preventative maintenance (PM) program and manage all maintenance activities, ensuring equipment and facility systems are in a state of control and operational readiness.
• Coordinate with external vendors and contractors for specialized maintenance, repairs, and system calibrations.
• Lead the troubleshooting and repair of facility equipment and systems, responding to non-routine maintenance needs and system alarms.
• Collaborate with cross-functional teams, including Engineering, Quality Assurance, Manufacturing, and Regulatory Affairs, to ensure a seamless and compliant CVC process and ongoing facility operations.
• Manage and coordinate validation and maintenance projects, ensuring all activities are completed on time, within budget, and in full compliance with internal and external regulations.
• Conduct risk assessments and root cause analyses for deviations or non-conformances related to validated systems or equipment failures.
• Serve as a subject matter expert (SME) on facility-related validation and maintenance topics during regulatory inspections (e.g., FDA, NRC) and internal audits.
• Maintain and manage the validation master plan and associated documentation for the facility.
• Stay up to date with current industry trends, regulatory requirements (e.g., 21 CFR §11, 21 CFR §211, and EU Annex 1), and best practices in radiopharmaceutical manufacturing and facility management.
• Provide technical guidance and training for other staff members on validation and maintenance principles and procedures.

Required Qualifications:

• Bachelor's degree in an Engineering discipline (e.g., Chemical, Mechanical, or Industrial) or a related scientific field.
• Minimum of 5 years of experience in a regulated pharmaceutical or biotechnology manufacturing environment, with a strong focus on facility, utility, and equipment validation and maintenance.
• Proven experience with Good Manufacturing Practices (GMP) and knowledge of regulatory requirements for pharmaceutical manufacturing.
• Demonstrated experience in authoring and executing CVC protocols (IQ, OQ, PQ) and managing maintenance programs.
• Strong technical writing, communication, and interpersonal skills.
• Ability to work independently and manage multiple projects in a fast-paced, dynamic environment.
• Familiarity with cleanroom design and operation, HVAC systems, and purified water systems.

Preferred Qualifications:

• Experience in the radiopharmaceutical or nuclear medicine industry.
• Knowledge of radiation safety principles and regulations (e.g., NRC).
• Experience with computer system validation (CSV) for building management systems (BMS) and computerized maintenance management systems (CMMS).