Senior Automation Engineer

This position will be a technical leader, working within the Radioisotope Processing Engineering Team. This position is responsible for the design, planning and execution throughout the product life cycle of system automation technologies. This includes gathering and prioritizing customer requirements and managing the implementation of novel radioisotope manufacturing technologies, as part of new and existing radiopharmaceutical sites. The Senior Automation Engineer will develop and execute automation engineering tasks from concept phase through design, planning, procurement and execution, as well as coordinating with vendors and contractors. The design through start up includes programming of PLC, HMI and Distributed Control Systems (DCS), designing of control loops and basic logic diagrams, as well as associated documentation. This will include advanced system automation design as related to; proficient system workflows, data interfaces between disparate systems and overall data management, which will be used for system tracking and trending.

This person is also responsible for working with cross functional teams, including RA/QA and Process Engineering 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. The Automation Engineer is critical to the company’s continued success and growth by providing technical leadership with regards to system automation with increasing levels of productivity and safety.

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

1. Lead responsibility for defining the overall automation strategy and architecture for Ursa Minor. This would include process control, process control network, batch/recipe processing, and integration with MES systems.
2. Lead the selection of vendors and management of automation integration partners. Be the primary point of contact.
3. Develop, plan, implement and support automation based projects and solutions in collaboration with cross-functional teams, including determination and delivery on cost, time and quality to ensure the sustained production, with an overall focus on productivity and safety. The projects may be within new facilities and/or retrofit of existing.
4. Design, Revise and commission PLC, HMI and DCS based technologies.
5. Design, code, test, debug and document programs and systems.
6. Provide advanced automation technical knowledge for troubleshooting, investigations and training.
7. Provide advanced automation system design in relation to data acquisition, integrity and retention, required for system tracking and trending, including development of data interfaces between disparate systems.
8. Ensure effective maintenance and availability of automation equipment.
9. Support the validation of automation systems per cGMP and Regulatory guidance.
10. Implement automation changes to existing control system hardware and software, supervising hardware and software modifications done by outside vendors, and development of specifications and testing documentation.
11. Creation, modification, and maintenance of automation system and documentation, including automation specification documents and SOPs, in a cGMP compliant state.
12. Support definition and implementation of best practice automation technical standards and procedures.
13. Understand P&ID drawings, electrical schematics and wiring diagrams.
14. Continuously adapt to an ever-changing regulatory environment such that the Company is in compliance with current regulations.
15. Provide engineering innovations that will improve process control and product quality.
16. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
17. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.

Ability and willingness to travel both domestically and internationally up to 15% 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.

Bachelor’s degree in Engineering and 8 or more years of automation engineering design and implementation of control systems software experience within a regulated pharmaceutical/medical device manufacturing environment; or equivalent combination of education and experience. Experience with PLC, HMI and DCS in Product Development Life Cycle ranging from product specification and concept development to product release. Experience with radioactive material processing a plus.

Demonstrated proficiency of PLC, HMI and DCS programming including databases and system interfacing languages. Proficient knowledge of Microsoft Office software programs including Outlook, Word, Excel, PowerPoint and Visio.
• Familiar with FDA 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.



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