Senior Process Engineer

About the Role

The Senior Process Engineer will be a key contributor in a dynamic manufacturing organization at the Noblesville, Indiana facility, supporting fast-paced manufacturing of Curium’s radiopharmaceutical therapeutic sterile drug products. This role focuses on developing solutions and implementing new technology to improve the reliability and quality of the manufacturing process through change controls and corrective and preventative actions. The position involves troubleshooting equipment issues and collaborating across functions including R&D, Project Management, Quality Assurance, Quality Control, Validation, and Manufacturing.

The ideal candidate has experience in pharmaceuticals, biologics, GMP manufacturing, or other highly regulated industries, with knowledge of automated visual inspection and labeling of vials.

Responsibilities

• 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 failures and propose corrective and preventive actions to eliminate root causes.
• 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.

Requirements

• Bachelor’s degree in Engineering (Mechanical Engineering preferred; chemical, biochemical, biotechnology, or other engineering disciplines considered based on 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 (e.g., medical devices or food processing) may also be considered.
• Verifiable knowledge of and experience in application of cGMPs, validation, quality systems, document control, and regulatory considerations.
• Strong project management and organizational skills, including the ability to work both independently and collaboratively.
• 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 highly regulated environments.
• Strong oral and written communication skills with the 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, requiring participation in safety programs to minimize potential and/or actual exposure levels.
• Ability to lift up to 70 pounds, kneel, crouch, twist the upper body, walk, bend, stoop, push, pull, and reach.
• Must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, conveyors) are used when possible; proper lifting and movement techniques are necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination and close attention to detail.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards (including corrosive, flammable, and toxic materials), dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekends, and holidays as business needs require.

Schedule

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