Process Maintenance Technician IV, 1st Shift Sun-Wed

3 days ago

Norwood, Massachusetts, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Process Maintenance Technician IV to join our team at our GMP Manufacturing facility in Norwood, MA. As a key member of our maintenance team, you will be responsible for the calibration, maintenance, and repairs of GMP/non-GMP process and support equipment.

Key Responsibilities
  • Perform preventative and corrective maintenance activities and calibrations to support process equipment and systems, in accordance with established procedures and/or approved practices.
  • Troubleshoot equipment and systems, and repair malfunctioning equipment. Work with equipment owners/engineers and direct the performance of work by equipment vendors.
  • Maintain cGMP records, both paper based and electronic.
  • Understand Asset Management and routine reliability concepts.
  • Provide technical expertise for the maintenance and repair of manufacturing and support systems/equipment such as autoclaves, washers, formulation, vial/syringes lines, inspection, and label/packaging equipment.
  • Perform calibrations in the following disciplines: Balances/scales, flow, temperature, conductivity, pressure, among others in a GMP/GXP environment.
  • Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities.
  • Provide on-call support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed.
  • Ensure that spare parts, tools, calibration standards and equipment are available to complete all assigned tasks.
  • Respond to alarms and document activities in accordance with cGMP requirements. Working with equipment owners and develop remediation activities for alarms.
  • Manage contract service providers; including scheduling, training on required SOPs, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements.
  • Administer and perform hazardous energy control procedures and confined space entry.
Requirements
  • AS or BS degree in a science/technical field or a technical trade school preferred.
  • Minimum 7 years of relevant experience working in a regulated (cGMP preferred) environment.
  • Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work.
  • Military training equivalent of above is acceptable.
  • Experience with Metrology.
Preferred Qualifications
  • Understanding of PLC controls for simple troubleshooting is preferred.
  • Excellent interpersonal and communication skills (verbal and written) are required. Ability to present own work to peers and cross-functional managers and influence leadership decisions.
  • Technical writing skills required.
  • Must have a customer service mindset.
  • Must be able use technical expertise and judgement to investigate issues using a structured problem-solving approach to determine true root cause and path forward for complex problems.
  • Demonstrated ability to learn new equipment/systems.
  • Familiarity with Excel, Word, and PowerPoint.
  • Ability to navigate computerized data and information management systems.
About Us

Moderna is a leading biotechnology company that is pioneering the development of mRNA-based therapeutics and vaccines. We are committed to improving the lives of patients and advancing the field of medicine.

We offer a comprehensive benefits package, including medical, dental, and vision coverage, as well as a 401(k) plan and paid time off. We are an equal opportunity employer and welcome applications from diverse candidates.

Join our team and be part of a dynamic and innovative organization that is shaping the future of medicine.

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