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 radiopharmaceutical 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.
Provides in-person technical support to Manufacturing so that radioactive product manufacturing and distribution schedules are met.
Effectively identifies and handles manufacturing challenges in all aspects of manufacturing equipment operation, maintenance, change control and validation.
Working hours: 8 AM - 5 PM
Proven record in a radiochemical/radiopharmaceutical 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.
Qualifications and 'call to action':
Associates degree or preferably 5 years related experience in a highly regulated manufacturing environment.
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.
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