Manufacturing Technicians (GMP)

  • location: North Billerica, MA
  • type: Permanent
  • salary: $54,400 - $64,000 per year

job description

Manufacturing Technicians (GMP)

Job Title: Engineering and Maintenance Technician II
Job Summary
  • Provides in-person technical support to Manufacturing so that radioactive product manufacturing and distribution schedules are met.
Job Responsibilities
  • 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 values of accountability, quality, efficiency, customer service, collaboration and safety.
Education & Qualifications
  • Associates degree or preferably 5 years related experience in a highly regulated manufacturing environment.
  • Proven record in a radio chemical/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.
Benefits
  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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