Provides in-person technical support to Manufacturing so that radioactive product manufacturing and distribution schedules are met.
Key Responsibilities/Essential Functions
- Effectively identifies and handles manufacturing challenges in all aspects of manufacturing equipment operation, maintenance, change control and validation.
- Routinely utilizes in depth working knowledge across a broad spectrum of equipment support skills including mechanical, electrical, control system engineering, process control, validation, industrial and radiological safety.
- Monitors processes using tools such as data browsers and SPC to identify trends and potential problems.
- Independently writes manufacturing, testing, maintenance and provisional process documentation related to radio pharmaceutical manufacturing.
- Troubleshoots basic to more complex problems with maintenance and calibration of equipment.
- Organizes and leads a project team or major repair. Establishes personal objectives which complement group and organizational goals.
- Writes and executes complex validation protocols and prepare data summaries for reports.
- Performs the duties of a protocol Study Director.
- Participates and/or leads fault-finding and route-cause analysis investigations as a technical resource.
- Sets priorities and performs preventive maintenance and emergency equipment repairs and monitors and adjusts daily/weekly schedules to ensure business needs are met.
- Utilizes own technical knowledge and /or coordinates the proper resources to resolve basic to complex manufacturing process problems.
- Provides coverage on off-hours and holidays.
- Makes appropriate decisions to ensure the highest quality standards are met when product is released
- Actively promotes safety rules and awareness.
- Demonstrates good safety practices at all times including the appropriate use of protective equipment.
- Reports and takes initiative to correct safety and environmental hazards.
- Actively demonstrates the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.
- Associates degree or preferably 5 years related experience in a highly regulated manufacturing environment.
- Proven record in a radiochemical/radio pharmaceutical support or development environment.
- Broad in-depth knowledge of our product processes and operations.
- Demonstrated proficiency in utilizing information technologies to analyze data and write technical reports.
- Demonstrated ability to write basic development and/or validation protocols and reports.
- Demonstrated ability to perform the duties of a Study Director for development or validation protocols.
- Demonstrated ability to work independently and in teams.
- Demonstrated ability to lead projects and/or teams for basic activities.
- Demonstrated ability to plan, implement & execute departmental programs or projects to achieve departmental objectives.
- Demonstrated ability to work with cross-functional groups in a complex, changing, and diverse environment.
- Demonstrated ability to continuously improve the manufacturing operation through innovative problem solving and proactive enhancements.
- Demonstrated ability to communicate information effectively to all levels in the organization in a manner that promotes productive relationships.
- Specific knowledge of multiple areas within product support (e.g. sterilization, process simulation, component manufacture etc.)
- Current in-depth knowledge of cGMPs, radiation safety techniques and regulations.
- Broad understanding of validation principles and methodology.
- Broad, in-depth knowledge of our product processes and operations.
- Broad understanding of scientific principles related to existing product and new product technologies.
- Strong knowledge of cGMPs, site safety policies and regulations.
- Strong interpersonal skills and an understanding of group dynamics.
Instructions to Apply:
Please visit http://www.lantheus.com/careers/overview/ to apply.