Summary of PositionThe Director of Process Engineering oversees key site engineering functions, including process engineering, product commercialization, capital and project delivery, process reliability, controls engineering, and project management. This role leads a team of technical professionals and partners with cross-functional departments to advance process engineering excellence in compliance with applicable regulatory standards and guidance. As a member of the Noblesville Site Lead Team, the Director helps shape site strategy, organizational development, and cross-functional alignment.
Work Schedule: Monday-Friday 8:00am 5:00pm
Essential Functions - Leads the transfer and commercialization of new products and processes at the site in partnership with R&D.
- Manages Process Performance Qualification and Validation Master Plan activities, including protocol development, execution, and final reporting.
- Partners with Regulatory to develop process and product content for new product submissions.
- Manages specifications for process-specific materials and components.
- Leads the development and maintenance of production batch records and related documentation.
- Owns all site Process Control Strategies and Process FMEAs.
- Oversees the development, review, approval, and execution of process equipment and automation activities in partnership with the site Validation team.
- Manages the development and maintenance of process and equipment documentation, including procedures, job aids, forms, on-the-job training, and qualification materials.
- Manages the specification and delivery of process equipment across the site, including capital planning and project management.
- Develops, maintains, and trends process metrics, including critical and key process parameters, in-process controls, yields, and finished-product release test results.
- Manages process reliability activities, including issue capture, prioritization, and completion, and provides key data and analysis for periodic Product Reviews.
- Oversees the timely completion of process-related nonconformances, CAPAs, change controls, and complaints.
- Supports all site quality audits and inspections.
- Partners with the site Maintenance team to establish robust spare-parts, preventive-maintenance, and calibration programs that maximize equipment reliability.
- Tracks and reports process-equipment metrics to identify improvement opportunities.
- Partners with Procurement to manage relationships and resolve issues with key equipment manufacturers.
- Leads the technical writing team in support of site initiatives.
- Promotes a culture of safety, compliance, and continuous improvement within Engineering.
- Provides ongoing coaching and professional development to strengthen team members' technical capabilities and regulatory knowledge.
- Conducts regular performance reviews and establishes clear objectives and performance measures.
- Partners with HR to recruit qualified talent aligned with the company's culture of excellence.
- Builds and maintains effective working relationships across the site and throughout Curium.
- 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 or a related field required; advanced degree preferred.
- At least 15 years of engineering experience in the pharmaceutical industry; radiopharmaceutical experience preferred.
- At least 10 years of leadership experience with responsibility for engineering functions.
- Demonstrated ability to establish a vision and lead cultural change.
- Experience leading cross-functional teams.
- Self-directed and fully accountable for department performance, deliverables, and timelines with limited supervisor guidance.
- Excellent verbal, written, and presentation skills.
- Ability and willingness to work near radioactive products.
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), including powered air purifying respirator (PAPR) and hearing protection as needed.
- May be required to sit or stand for long periods of 8+ hours a day while performing duties and donning appropriate PPE.
- 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.
Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Job Segment: Process Engineer, Nuclear Engineering, Engineer, Controls Engineer, Technical Writer, Engineering, Technology
