Senior Process Engineer

Summary of Position

The Senior Process Engineer will be a key contributor in a dynamic organization.  The role will implement new product projects in support of Curium’s growth strategy in radiopharmaceutical therapeutic sterile drug products. Projects can include technical transfer, new and generic drug development, conceptual design, scoping and estimation, integration, etc. 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 through all phases of projects from concept evaluation through commercial product launch. 

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

Essential Functions

• 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)  
• Involvement in product launch activities preferred. 
• Work collaboratively to quickly move projects from scoping to implementation. 
• Provide Aseptic Manufacturing experience and guidance of evaluation and design of new processes. 
• Partner with Quality to ensure good quality and cGMP practices and their implementation in new product launch. 
• Provide input to forecast estimates for project related costs and general project task tracking for adherence to project milestone goals. 
• Must maintain operational compliance with US and international requlatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

• Bachelor Degree in Chemical Engineering preferred or related field such as Bioengineering, Chemistry, and Biotech. 
• Five years or more of relevant experience while working in cGMP manufacturing environments. Significant experience in optimization of processes, including establishment of process KPI’s. 
• Experience in pharmaceuticals desired, however willing to consider other development areas such as medical devices experience. 
• Experience with medical isotopes preferred.
• Strong project management and organizational skills, including ability to work independently as a team member. 
• Knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products preferred. 
• 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.

Competencies