Senior Process Engineer

Curium Pharma; Maryland Heights (MO); Sur place; USD 110 000 - 160 000; Plein temps

Résumé du poste

The Senior Process Engineer at Curium Pharma Noblesville, IN will lead process improvements for radiopharmaceutical manufacturing, developing solutions and implementing new technology to enhance reliability and quality.

You will write protocols, support deviations, participate in cross-functional teams (R&D, QA, Validation, Manufacturing), and help launch new manufacturing lines while ensuring cGMP compliance.

Qualifications

• Bachelor degree in Engineering; Mechanical preferred, others considered.
• Five+ years of experience in cGMP manufacturing environments.
• Experience in process optimization and KPI development.
• Knowledge of automated visual inspection and pharmaceutical packaging is desired.
• Strong QA/validation, document control, and regulatory awareness.

Responsabilités

• Lead process improvement and troubleshooting of manufacturing processes or equipment.
• Support cross-functional projects 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 root causes and propose corrective and preventive actions.
• Support product launch activities and implementation of new manufacturing lines.
• Work collaboratively to 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 milestones.
• Assist in development and maintenance of process equipment, procedures, batch records, and training materials.

Connaissances

Process optimization

Project management

Communication

Cross-functional collaboration

Root Cause Analysis

Agile

Lean Six Sigma

cGMP knowledge

High-pressure environments

Travel willingness

Formation

Bachelor's degree in Engineering

Mechanical Engineering degree preferred

Description du poste

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.

Job description:

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 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.

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, 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.

Requirements

• 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 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 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, weekend, and holiday work as business needs require.