Development Engineer

The Development Engineer position will work in group with other Development Engineers, and will report into the Sr. Manager of Downstream R&D. The successful candidate will serve as a key functional core team member, as required, and will support, or may serve in a lead role, the technology transfer of processes from initial product conception to cGMP manufacturing. The Development Engineer will be responsible for working in collaboration with other R&D personnel, project engineering, quality assurance, quality control, validation, and manufacturing through all phases of projects, from concept evaluation through commercial product launch.

• Support new product development in an R&D setting.
• Work with a variety of compounds including liquids, gases, and solids of radioactive and nonradioactive materials.
• Authoring and documentation of new process development and tech transfer experiments.
• Data analysis to support experimental results. Six Sigma certification preferred, with experience using Minitab, or other statistical software.
• This role has responsibility for adding additional techniques to their expertise that provide backup capability for the R&D organization.
• Analyzing processes to improve recovery, through-put, and scalability.
• Utilization of product formulation technologies and automation to establish, and optimize, new processes for incorporation into product manufacturing.
• 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.).

• Bachelor Degree in Chemistry, Chemical Engineering, Biochemistry, Biology,
• Life Sciences, or related field with 3 years of pharmaceutical industry experience (Radiopharmaceutical experience highly preferred).
• Pharmaceutical industry experience with familiarity with cGMP, FDA, USP, NRC, and ICH guidelines.
• Hands-on experience in manufacturing and laboratory settings.
• Strong organizational skills, including ability to work independently, and as the member of a cross-functional team.
• Proven experience with problem solving and implementation of corrective actions.
• Behavioral requirements for success in this position include: self-starter, drive for results, and integrity and trust.
• Excellent written and verbal communication skills.
• Experience with data collection and analysis.
• Experience with Microsoft Word, Excel, and Visio software.
• 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.).

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.