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 Process Engineer provides technical discipline and leadership required to maintain, plan and implement robust and capable processes. Identifies and implements improvements and new technologies to processes to improve safety, increase productivity, improve quality, and reduce costs. The Process Engineer is the leader of equipment troubleshooting efforts; coordinating other support groups to return equipment to service. Is the leader of product/process failure investigations; implementing corrective actions and preparing sound scientific reports. Authors and provides technical support for developing processes and equipment documents including URS, DOE and validation documents. Provides change control authority to ensure the validated status of equipment is maintained. Reviews, monitors and trends daily operating data, issues reports and recommendations based on the data. Technical requirements include a thorough knowledge of cGMP's and applicable Industry standards.
Schedule:
- MondayFriday (5 eight-hour shifts)
- 7am to 3:30pm
- Ability to work over 40 hrs/week when necessary
Essential Functions
- 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.).
- Compose User Requirements Specifications (URS), Protocols, Change Control Test plans, and other associated validation documents for equipment and process upgrades.
- Maintain control of area process changes and serve as the primary departmental owner of equipment management of change activities.
- Provide adequate and documented monitoring of the process through trending, run reports, and tracking Key Process Indicators (KPI).
- Use data driven approach to identify process improvements.
- Lead the Reliability team and track progress of key initiatives.
- Lead process troubleshooting efforts.
- Assist in the development and maintenance of process equipment, procedures, batch records, and training materials.
- Investigate customer complaints and complete CAPA items.
- Identify capital needs for the process.
- Support departmental change initiatives for continual improvement, specifically around Operational Excellence, 6-Sigma and Lean Manufacturing applications.
- Primary departmental driver for cost reduction initiatives.
- Facilitate technical transfers with R&D.
- SME for the process.
- Provides technical expertise to project management teams during project lifecycles.
- Executes medium complexity projects, including:
- Purchases of low cost equipment (lab furniture, laboratory equipment, process research equipment, etc.)
- Composing associated CAR and processing financial information.
- Capital funding for outside services as it relates to manufacturing (risk assessments, validation services, process engineering assistance).
Requirements
- Bachelor Degree in Mechanical or Chemical Engineering required. (Other science or engineering degrees will be considered based on experience.)
- 3 or more years of experience working as an engineer in an FDA regulated facility required.
- 3 or more years of Manufacturing Experience; preferably in the manufacture of pharmaceuticals.
- Verifiable knowledge of and experience in application of cGMP's, validation, quality systems, document control and the impact of regulatory considerations on engineering initiatives.
- Experience in applied knowledge of aseptic behaviors and techniques associated with pharmaceutical production.
- Proven experience in leading teams, groups or efforts relating to processes and equipment.
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: Process Engineer, Chemical Research, Facilities, Nuclear Engineering, Medical Technologist, Engineering, Operations, Healthcare