The Manufacturing Engineer is responsible for executing manufacturing process development and production support of mechanical assembly. This position will coordinate the ongoing product and process improvements to meet quality and production goals. The Manufacturing Engineer II will also be responsible for executing production support of mechanical assembly.
All duties and responsibilities will be done in compliance with cGMP and FDA regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Execute manufacturing process development including mechanical, electrical, tubing, and disposable/consumable assembly processes.
2. Work directly with product development to develop/execute design transfer plans for new products.
3. Execute manufacturing process development and documentation including work instructions and batch production records.
4. Develop scale up/automation of manual processes.
5. Develop test systems for electromechanical devices and disposable components including development of custom test systems.
6. Execute production support of mechanical assembly, chemical/fluid, filling, packaging processes in pharmaceutical clean room environments.
7. Execute ongoing product & process improvements to meet quality and production goals.
8. Execute Factory/Site Acceptance Testing of complex custom equipment.
9. Develop/execute standards/processes for qualification and process validation
10. Analyze and improve material/people flows, process layouts to optimize plant efficiency
11. Ensure production equipment is capable and has capacity for growth, involving integrating equipment, people, material flow systems, and information systems.
12. Support complaint/event/CAPA/deviation/out of specification investigations
13. Prepare cGMP procedures, reports, and plans.
14. Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
15. Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures.
This role may require spending 1-2 days a week at our Madison facility. In addition, the ability to travel internationally and domestically could be required, this is expected to be less than 10% 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 EXPERIENCE
Bachelor’s Degree in Engineering from an accredited college or university and 1-3 years of experience as a Manufacturing Engineer; or equivalent combination of education and experience. Experience executing process validation and documentation activities (IQ/OQ/PQ) is required. Experience with FDA regulations, cGMP regulations, and pharmaceutical/medical device industry is preferred.
Proficient knowledge of Microsoft Office Suite software programs
- Strong Multi-tasking skills
- Excellent problem solving skills
- Strong organizational and communication skills.
- Strong Mentorship skills.
If you are interested in applying for this position, please forward your resume to firstname.lastname@example.org with the position title in the subject line