Manager, Automation Engineering
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.
The Factory Controls and Automation Manager will work to develop automation and control systems for medical radioisotope processing systems including particle accelerator based systems. The position will lead engineers in developing detailed system requirements, including documentation, development, procurement, system build, commissioning and qualification testing. This position will include management of internal resources programming PLC and HMI, as well as selection and management of outside vendors providing services to support NorthStar’s automation requirements. This role will also lead the development and testing of Manufacturing Execution Systems (MES) and associated networking and data management systems. This individual will be required to work with cross functional teams, including RA/QA and Process Engineering to apply efficient cGMP processes to preserve data integrity and the quality of the final drug product, including the safety of all production and non-production personnel.
All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Develop strategy, build staff, and led the team responsible for
a. Design, revise, and commission controls based systems with input from cross-functional teams and senior staff.
b. Design, code, test, and debug programs and systems.
c. Create and implement designs that operate in high radiation, high RF environments.
d. Integrate commercial and custom control system hardware and software.
e. Create, modify, and maintain automation system documentation including project documentation, specification documents, and SOPs in a cGMP compliant state.
f. Troubleshooting various controls systems, both in software and hardware, and provide training to operations personnel on controls operations.
g. Understand and create electrical schematics and wiring diagrams and present drawings and project progress to peers and management
2. Ensure effective maintenance and availability of controls equipment.
3. Lead the validation of automation systems per cGMP and Regulatory guidance.
4. Participate in process risk and hazard reviews and modify equipment/designs as necessary to ensure safe operation and appropriate specifications are captured.
5. Review internal user requirements to design and implement new Automation Systems and modify existing Systems.
6. Responsible for working with OEM vendors to ensure product design, architecture and hardware conform to overall process requirements
7. Assist production and service personnel in troubleshooting automation systems. Assist in developing service manuals, procedures and maintenance related documentation.
8. Provide support to qualification and engineering personnel involved in automation FAT’s and SAT’s
Ability and willingness to travel both domestically and internationally up to 5% of the time. This role will require significant work in our Beloit Manufacturing Location which could peak to 100% of the time during system validation periods.
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 an associated discipline, and 10 or more years of experience with a concentration in Controls Engineering, including both software and hardware; or combination of education and experience. Knowledge of hardware design and maintenance. Specific knowledge of Siemens automation products (SIMATIC), experience and working in a regulated pharmaceutical/medical device manufacturing environment is preferred.
Demonstrated proficiency of PLC and HMI programming including databases and system interfacing languages. Experience with AutoCad Electrical or comparable design software. Proficient knowledge of Microsoft Office software programs including Outlook, Word, Excel, PowerPoint and Visio.
• Familiar with FDA regulations (21 CFR Part 210, 211, and Part 11)
• 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