Process Engineer Jobs in Chesterfield, MO (NOW HIRING)

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Maryland Heights, MO, United States, 46060

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

The Senior Process Engineer will be a key contributor in a dynamic manufacturing organization at the Noblesville, Indiana facility. The role will support fast-paced manufacturing of Curium’s radiopharmaceutical therapeutic sterile drug products. The role will develop solutions and implement new technology to improve the reliability and quality of the manufacturing process through writing and implementing change controls and corrective and preventative actions. Additionally, the role will troubleshoot equipment issues. The Senior Process Engineer will work collaboratively in a cross-functional organization with R&D, Project Management Organization, Quality Assurance, Quality Control, Validation, and Manufacturing.

The ideal candidate would have experience in pharmaceuticals, biologics, GMP manufacturing, or within highly regulated industries. The ideal candidate would also have knowledge in automated visual inspection and labeling of vials.

Work Schedule: Monday-Friday, 8:00a.m.-5:00p.m. Hours may be adjusted based on business needs.

• Lead process improvement, reliability improvements, troubleshooting, and remediation efforts related to manufacturing processes or equipment.
• Support cross-functional projects and project teams through process evaluation, design, and implementation of robust processes for new products within existing or new manufacturing equipment.
• Write technical documentation, including protocols and reports for equipment and process improvements.
• Author deviations to investigate the root cause of a failure and propose corrective and preventive actions to eliminate the root cause.
• Support product launch activities and implementation of new manufacturing lines.
• Work collaboratively to quickly move projects from scoping to implementation.
• Partner with Quality to ensure implementation of cGMP practices.
• Provide input into forecasts for project-related costs and track project tasks against milestone goals.
• Assist in the development and maintenance of process equipment, procedures, batch records, and training materials.

• Bachelor degree in Engineering. Mechanical Engineering is preferred; chemical, biochemical, biotechnology, or other engineering disciplines will be considered based on professional experience.
• Five or more years of relevant experience in cGMP manufacturing environments.
• Significant experience in optimization of processes, including establishment of process KPIs.
• Experience in automated visual inspection or pharmaceutical packaging is desired; experience in other regulated industries, such as medical devices or food processing, may also be considered.
• Verifiable knowledge of and experience in application of cGMPs, validation, quality systems, document control and the impact of regulatory considerations on engineering initiatives.
• Strong project management and organizational skills, including the ability to work both independently and collaboratively as a team member.
• Experience leading formal Root Cause Analysis and problem-solving methodologies.
• Technical understanding of the pharmaceutical development process from concept to launch.
• Proven collaborative experience within complex multi-discipline project teams in a highly regulated environment.
• Strong oral and written communication skills with proven ability to communicate effectively at all levels in high-pressure environments.
• Agile approach and willingness to learn new things – ability to work “on the fly” in a dynamic setting.
• Intermittent travel may be required up to 10% of the time.
• Lean and/or Six Sigma certification preferred.

Working Conditions:

• Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and