Principal Process Engineer

The Principal Process Engineer will work in a dynamic organization in the New Product Initiatives (NPI) team for North America. This role has the responsibility for supporting and implementing projects related to Curium's business strategy in the space of sterile drug manufacturing including reactor and cyclotron derived new products. This role will help support activities associated with BD&L, M&A, PMO, and CMO activities. Projects can include technical transfer, drug development, conceptual design, scoping and estimation, integration, etc. The Principal Process Engineer will be responsible for working in collaboration with R&D, project engineering, quality assurance, quality control, validation, and manufacturing through all phases of projects from concept evaluation through commercial product launch.

• Support large cross-functional projects and project teams through process evaluation, design, and implementation of robust processes.
• Technical evaluation of new products relative to current site processes; process design for new products within existing or new manufacturing equipment
• Experience with product start-up and coordinating product launch activities preferred.
• Work collaboratively with the Manager of Engineering and the Project Manager to quickly move projects from scoping to implementation.
• Provide Aseptic Manufacturing expertise and guidance of evaluation and design of new processes.
• Partner with Quality Leadership to ensure 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 regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelordegree in Chemical Engineering or related field required (other disciplines may be considered based on professional experience.)
• 8 or more years of relevant work experience required.
• Considerable experience in optimization of processes, including establishment of process KPI's.
• Experience in pharmaceuticals desired but willing to consider other development areas such as medical device experience.
• Experience with medical isotopes preferred.
• Strong project management and organizational skills, including ability to work independently and as a team member.
• Experience with radiation safety programs (preferred but not required).
• Knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products, including lyophilization preferred.
• Ability to read PFDs and PIDs.
• Knowledge of current industry practices and technologies.
• Familiar with project management tools and best practices.
• Experience applying formal Root Cause Analysis and problem-solving methodologies.
• Proven ability in setting priorities and organizing work to meet deadlines.
• Technical understanding of the pharmaceutical development process from concept to launch.
• Proven experience within complex multi-discipline project teams in a highly regulated environment.
• Strong oral and written communication skills with the ability to communicate effectively in high pressure environments.
• Ability to react to problems and lead the team to develop solutions while communicating effectively to project leadership and stakeholders.
• Ability to maintain collaboration in a result driven environment.
• Agile approach and willingness to learn new things - ability to work "on the fly" in a dynamic setting.
• Advanced skills with Microsoft Office (Excel, PowerPoint, SharePoint, Word), MS Project and Visio; experience with Smartsheet preferred.
• Intermittent travel, including international, may be required up to 5% of the time.

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.