Senior Process Engineer at Curium · Noblesvil…

Summary of Position

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 aseptic manufacturing of vials with automated equipment.

Work Schedule: Monday - Friday 8:00am - 5:00pm. Hours could be adjusted.

Essential Functions

• 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 (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing)
• 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.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

• Bachelor’s 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.
• Knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products preferred.
• 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 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 inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is 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; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, 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, weekend, and holiday work as business needs require.