Process Maintenance Technician

The Process Maintenance Technician will maintain NorthStar’s process equipment. This position will develop and execute preventive maintenance of specific production equipment including, but not limited to, cleanrooms, conveyors, hot cells, and process utility systems. This position will be working within a cGMP space and must be able to properly document and execute all activities. This position will be providing assistance to Research and Development Engineers and Process Engineers to identify, document and control equipment used in NorthStar’s cGMP defined areas.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:

1. Work with engineering to size, purchase, install and maintain production equipment and fixtures.
2. Troubleshoot, test and maintain electro-mechanical, electronic, mechanical, and pneumatic fixtures and systems as needed.
3. Troubleshoot, test, and maintain laboratory equipment.
4. Perform qualification and/or re-qualification on equipment as required.
5. Draft and execute SOPs and PMs as necessary.
6. Assist in tracking GMP equipment for calibration and PM activities and oversee any onsite calibration services to ensure quality and proper documentation.
7. Perform basic fabrication, such as cutting, drilling, and welding.
8. Follow SOPs and document all work as necessary.
9. Support Engineering, Production and Facilities departments for equipment and testing.
10. Participate in investigations as necessary. Administer events, deviations, and CAPAs as required.
11. Create, enter data into, and close work orders in a CMMS as necessary, including assisting with new equipment onboarding.
12. Operate material handling equipment and aerial platform lifts as needed.
13. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
14. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.

Ability and willingness to travel up to 20% of the time.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Technical Degree in Electro-Mechanical Technology, or similar field, and two or more years of experience within an FDA regulated manufacturing environment; or equivalent combination of education and experience. Experience with PLC programming and Lock Out Tag Out procedures is preferred.

Knowledge of Microsoft Office software programs, including Excel, Word, and Outlook. Experience with automation and a CMMS is preferred.

• Excellent communication skills, verbal and written
• Ability to handle multiple tasks simultaneously
• Ability to work in a fast-paced environment, with a cross functional team.
• Ability to work in a team environment, as well as independently
• Adaptable to change in the work environment, including “On Call” availability.

If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.



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