Sr. Equipment Engineer

Senior Engineer, Equipment Engineering

Senior Engineer, Equipment Engineering is an integral part of bringing Rayze Bio's innovative drug products to patients in need. In this role, you will report directly to the Associate Director, Equipment Engineering and be primarily responsible for equipment engineering projects supporting clinical and commercial manufacturing objectives at the Indianapolis site(s). You will design, develop, improve, and support validation and life cycle management of process equipment with novel Radiopharmaceutical technologies including but not limited to custom Hot Cells, formulation, and filling lines.

Additional responsibilities will include working with engineering firms and specialty equipment manufacturers to achieve our clinical and commercial manufacturing objectives.

Job Responsibilities

• Accountable for continuous operation and maintenance of process equipment for Radiopharmaceutical Clinical and Commercial manufacturing.
• Lead engineering expansion projects specific to innovative isotope and drug product radiopharmaceutical manufacturing.
• Lead development and maintenance of departmental procedures and processes related to equipment engineering activities.
• Support GMP manufacturing operations by leading and/or contributing to deviation investigations, CAPA development and execution, and change control activities, with on-call responsibility during evenings, weekends, and other non-standard business hours.
• Collaborate with Production, Quality, Digital IT, Validation and Facility Engineering counterparts to support clinical and commercial manufacturing, development and implementation of novel radiopharmaceutical technologies.
• Lead projects related to external vendors, partners and service providers as required for the design and implementation of novel radiopharmaceutical isotope and drug product equipment technologies.
• Comply with site EHS and Radiation Safety programs.
• Review, author and/or revise technical documents (SOPs, URS's, forms, reports, etc.) as needed.
• Ability to travel as required to support job role.

Education and Experience:

• Minimum 5+ years' engineering experience on equipment is required.
• Experience in cGMP Biopharmaceutical or Radiopharmaceutical or medical device environment equipment engineering design, development and validation is preferred.
• BS in Engineering degree required / MS in Engineering degree preferred.

Skills:

• GMP manufacturing equipment engineering experiences in Bio Pharma or Medical Device.
• Experience in GMP, validation, regulatory standards, and industry best practices.
• Experience managing engineering projects.
• Working knowledge of Robotics.
• Experience in clinical or commercial manufacturing of drug products or medical devices.
• Commitment to continuous improvement and operational excellence.
• Excellent professional ethics, integrity, and ability to maintain confidential information.
• Organized and detail oriented.
• Strong time management and organizational skills.
• Strong interpersonal communication skills.
• Motivated, adaptable, accountable and collaborative. Be able to support in a manufacturing environment under pressure.
• Uses AI tools to enhance individual productivity and quality of work

Physical Requirements:

• Standard office environment coupled with GMP production and facility environment.
• Responsibilities also include the ability to lift 50 lbs., walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
• Ability to sit or stand for long periods of time while performing duties.
• Must be willing to wear personal protective equipment (PPE) as required.
• Must be comfortable working with radioactive materials.

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.