Director of Process Engineering & Manufacturing Excellence

Curium Pharma; Noblesville (IN); On-site; USD 150,000 - 190,000; Full time

Job summary

Curium in Noblesville, IN, is seeking a Director of Process Engineering to lead site engineering, process commercialization, and capital projects. You will guide a technical team, partner with R&D and Regulatory, and ensure compliance with cGMP and applicable standards.

The role requires extensive engineering leadership in a radiopharmaceutical environment, with a focus on process performance, validation, and continuous improvement.

Qualifications

• Bachelor’s degree in engineering or related field required.
• 15+ years of engineering experience in the pharmaceutical industry; radiopharmaceutical experience preferred.
• At least 10 years of leadership experience in engineering.

Responsibilities

• Leads transfer and commercialization of new products and processes.
• Manages Validation Master Plan activities, including protocol development and reporting.
• Partners with Regulatory to develop process/content for new product submissions.
• Oversees development and maintenance of process documentation and batch records.
• Drives process reliability, CAPAs, change controls, and cross-functional collaboration.

Skills

Leadership

Cross-functional teams

Regulatory awareness

Mentoring/Coaching

Project management

Education

Bachelor's degree in engineering

Advanced degree preferred

Job description

Curium in Noblesville, IN, is seeking a Director of Process Engineering to lead site engineering, process commercialization, and capital projects. You will guide a technical team, partner with R&D and Regulatory, and ensure compliance with cGMP and applicable standards.

The role requires extensive engineering leadership in a radiopharmaceutical environment, with a focus on process performance, validation, and continuous improvement.