Principal Quality Testing Engineer Job Details | curium

About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Principal Quality Testing Engineer acts as the subject matter expert and technical lead in method validation, verification, optimization and transfer. Leads efforts to identify and assess analytical techniques and instrumentation best able to meet requirements to characterize new products. Serves as a technical mentor to QC analysts and provides technical counsel concerning the scientific content of methods, analytical testing, instrumentation, evaluation and interpretation of laboratory data, assisting in OOS investigations, and other QC related issues as required.

Schedule: Monday Friday 8am 4:30pm

Essential Functions

• Identifies and leads in implementing the strategy for method validation, verification and transfer. Authors associated protocols. Mentors other QC Analysts in the creation and execution of method validation, verification and transfer protocols.
• Coordinate with vendors to identify and evaluate analytical techniques and instrumentation suitable to meet requirements to characterize products and/or analytes. Gather information from vendors regarding cost, installation, calibration and maintenance plans for new equipment in support of method validation, verification or transfer. May author Standard Operating Procedures for new instruments/software.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EP, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
• Author Change Controls, Protocols, Corrective and Preventive Action items and Periodic Reviews. Assure compliance with department training and qualification.
• Work safely with radioactivity and ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.
• Provides technical counsel concerning the scientific content of methods, analytical testing of samples, evaluation and interpretation of laboratory results, and other QC related issues as required.
• Authors Change Controls in Quality Management systems.
• Assists laboratory personnel with the process of instrument repair and troubleshooting, qualification and validation, and training.

Requirements

• Bachelor of Science Degree in Chemistry, or other science related field is required.
• Eight or more years of relevant experience required.
• Extensive knowledge of laboratory instruments/methods such as HPLC, GC, IC, ICP-MS, FTIR, UV, wet bench methods, etc.
• Lean Leader/Operational Excellence/5S preferred.
• Root Cause Analysis tools (Fishbone, 5 Why, Is/Is Not, etc.) 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.

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.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job Segment: QA Tester, Quality Engineer, Medical Technologist, Nuclear Engineering, Testing, Engineering, Quality, Healthcare, Technology