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 has developed a groundbreaking isotope processing production equipment and an instrument/medical device that will efficiently produce important medical Radioisotopes on site at a Radiopharmacy.
Description of role
NorthStar is in search of a hands on engineering manager who will lead an organization responsible for managing multiple greenfield manufacturing plant construction projects regulated by pharmaceutical standards. These facilities will include processes such as drug formulation and filling, packaging, medical device assembly, as well as particle accelerator based processing. In addition this role will oversee the facility management of our existing manufacturing and R&D facilities. The successful candidate will bring the structure and rigor associated with a large organization while being able to function in a smaller, more hands- on environment. This leader will be a key member of the engineering organization leadership team.
- Health Insurance
- Dental insurance
- Vision insurance
- Tuition reimbursement
- Retirement plan
- Responsible for the development and execution of construction projects, including setting requirements, cost estimating, budgeting, selection/management of engineering and construction contractors, evaluating bids, design drawings, and implementing change control.
- Establishing and coordinating project management tools for capital building projects, as well as managing subordinates in maintaining project tracking tools.
- Lead the resource planning, hiring and supervision of direct reports. Training and mentoring a dedicated team of engineers and related professionals.
- Inspect construction and repair progress to ensure conformance to established specifications, along with conformance to lease requirements and building codes.
- Create and manage departmental budget.
- Lead the design, execution, and maintenance of all process utilities.
- Lead the design, construction, maintenance of all office space and R&D facilities.
- Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
- Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures.
- Ability and willingness to travel up to 5% of the time, will need to ability to travel to Madison, WI for occasional meetings.
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
- Bachelor’s degree in Engineering or Architecture
- 5+ years of experience in facility construction, preferably in a medical or pharmaceutical manufacturing environment
- 3+ years of management experience; or equivalent combination of education and experience.
- Experience working with FDA regulations, GMP manufacturing requirements, and radioactive processing preferred.
- Proficient knowledge of MS Office software programs and some knowledge of engineering tools including AutoCad and/or Solidworks.
- Ability to successfully plan, motivate, enhance and assist direct reports to ensure a healthy work environment.
- Must be able to fairly evaluate and ensure compliance to NorthStar’s employment policies.
- Ability to read and comprehend all documents including complex proposals, safety rules, operating and maintenance instructions, procedure manuals and governmental regulations.
- Ability to write detailed reports and correspondence on specifically assigned subject matter.
- Ability to speak effectively before groups of customers, NorthStar’s management or employees of the organization.
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Ability to solve complex relational problems with many unrelated variables.
- Strong organizational and time management skills
- Excellent communication skills, verbal and written
- Strong problem solving skills
- Ability to handle multiple projects simultaneously
- Ability to interact effectively with all levels of management and team members
- Adaptable to change in the work environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand and walk and occasionally required to sit. The employee frequently is required to stoop or kneel. The employee is regularly required to reach with arms and use hands to finger, handle, or feel. The employee must frequently lift and/or move up to 75 pounds. The employee is regularly required to speak and hear. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. The environment is a well-lit, heated, and/or air- conditioned indoor office/production setting with adequate ventilation.
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Job Type: Full-time
- Microsoft Office: 2 years (Required)
- facility construction: 5 years (Required)
- Management: 3 years (Required)
- working in medical or pharmaceutical manufacturing: 2 years (Preferred)
- FDA Regulations: 1 year (Preferred)
- CGMP: 1 year (Required)
- Beloit, WI: Between 31 and 40 miles (Required)