Plant Engineer - Accelerator Facility
NorthStar’s mission is to transform the medical radioisotopes industry by becoming a global leader of innovative diagnostic & therapeutic medical radioisotopes. In fulfillment of this mission, NorthStar continues to develop groundbreaking isotope processing methods.
NorthStar is in search of a Plant Engineer to assist the development of a particle accelerator based radioisotope processing facility. This position will support the design, planning, construction, and maintenance of buildings, utilities, and associated property at NorthStar’s planned facility that will house its accelerator project. This position will also act as the technical leader for design and maintenance of GMP R&D and production facilities. All projects and duties will be completed in compliance with applicable cGMP, FDA, OSHA and all other regulatory agency standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Support the planning, construction, and maintenance of manufacturing system facilities.
2. Support facilities functions to ensure facilities are prepared at all times for FDA inspections and are in compliance with applicable regulations.
3. Lead the planning, approval and execution complex or multi-trade projects requiring engineering design or design by outside consultants or contractors.
4. Provide support for unplanned, unexpected or urgent facilities issues which require immediate action.
5. Effectively communicate to NorthStar staff to reduce and minimize impacts of facilities projects to business operations.
6. Maintain current and accurate facilities drawings which accurately show any modifications, alterations or improvements to the facilities or facilities systems.
7. Support the Environmental, Health and Safety Program to maintain compliance with OSHA and all other applicable regulatory agency standards.
8. Support facility process performance metrics, including analyzing, tracking, and reporting workload, quality, safety, and cost performance for facilities and utilities.
9. Analyze, develop and support maintenance of building automation systems for controlling, monitoring, alarming, and reporting building utility systems performance.
10. Overseeing contractors or vendors performing work within NorthStar facilities to ensure work is performed correctly and meets requirements.
11. All written documents shall comply with GDP.
12. Effectively communicate safety and quality issues raised by customers, or staff in a timely manner.
13. Support NorthStar’s Quality System and Health and Safety Program by following policies and procedures.
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.
EDUCATION and/or EXPERIENCE
The level of this position will be set commensurate with experience.
1) Bachelor’s degree in Engineering.
2) Demonstrated ability to work within a multidisciplinary team.
1) Experience/internships in medical devices, the pharmaceutical industry, or radiological and radiation buildings
OFFICE COMPUTER SKILLS
Proficient knowledge of Microsoft Office software programs including Outlook, Word, and Excel.
• Understanding of federal, state, and local building codes and regulations
• Excellent communication skills, verbal and written
• Ability to handle multiple tasks simultaneously
• Ability to work in a fast-paced environment
• Adaptable to change in the work environment
• Ability to work in a team environment, as well as independently
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.