Manager, Automation Engineering

Overview

Accelerate your career with NorthStar!

NorthStar Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner.  We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services.

At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities. 

Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, paid parental leave and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

Position

The Manager, Automation Engineering will be accountable for the development, testing, implementation and automation support of automation and control systems for radioisotope processing systems in compliance with FDA/cGMP regulations and standards.  This position will lead engineers through development of detailed system requirements, procurement, system build-out, commissioning and qualification testing.  The manager will also be accountable for automation support of equipment that is used for isotope manufacturing.  This position will include management of internal resources, as well as selection and management of outside vendors providing services to support NorthStar’s automation requirements.  The Manager, Automation Engineering is responsible for working with cross functional teams to apply efficient cGMP processes, which preserve data integrity and the quality of the drug product, including the safety of all production and non-production personnel.

This position supports 24 hour per day, 7 day a week production in a manufacturing facility and will require on-call availability to provide support as needed.

Responsibilities

• Develop and manage a team of Automation Engineers responsible for the development, specification, design, installation, and implementation of various automation and control systems, as well as support, maintenance, and upgrade of existing systems in accordance with FDA/cGMP requirements.
• Set objectives for the team in support of company goals, prioritize projects, and ensure workload is balanced.
• Develop project plans, schedules, and other project documentation. Track progress to schedule, guide team to meet deliverables, and hold individuals accountable for deliverables.
• Anticipate and mitigate risk points. Make tradeoffs between design complexity, time and effort, schedule, cost, and quality while meeting safety and regulatory requirements.
• Investigate, recommend, and assist in vendor/equipment selection and system design decisions.
• Lead resource planning and hire, train, and mentor new team members.
• Oversee the development of principles and processes including requirements, specifications, architecture, standards, design standards, review processes, test methods and change control.
• Lead Technical Reviews and/or Design Reviews.
• Prototype, test, verify, and validate automation/controls systems.
• Perform make/outsource analysis of new automation/control systems and support selection of manufacturing partners.
• Oversee execution of outsourced automation partners.
• Support process risk and hazard reviews and implementation of necessary specification, equipment, or design modifications to ensure personnel safety.
• Support strategic initiatives for the department such as budget planning, goal setting, and standardization of process.

Qualifications

Bachelor’s degree in Engineering, or an associated discipline, and minimum six (6) years of automation engineering design and implementation, ongoing support of control systems software, and automation hardware experience; or equivalent combination of education and experience.  Two (2) years leadership experience supervising direct reports as a leader of a team required. Leadership experience with a team of automation engineers preferred.  Specific knowledge of Siemens automation products and experience in a regulated environment (pharmaceutical, food, etc.) is preferred.  Bachelor’s degree or higher education is preferred.  Experience with PLC, HMI, and PCS in Product Development Life Cycle ranging from product specification and concept development to product release. 

Working Conditions

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.

The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures.  The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions.  Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols.  This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment.  In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders. 

The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.

Location

NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.

Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.

NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.