Senior Manufacturing Engineer
The Senior Manufacturing Engineer is responsible for the development and implementation of simple to complex manufacturing process designs for the NorthStar radioisotope manufacturing team in compliance with cGMP regulations. This position will be responsible for defining and creating new procedures for documenting or qualifying equipment and processes used in the manufacturing of radioisotopes. This position will also assist in overseeing the day-to-day production requirements of the Mo-99 fill process at the NorthStar Columbia facility.
The successful candidate will be familiar with manufacturing within the medical device/pharmaceutical industry and possess in-depth engineering knowledge in science.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Collaborate with internal and external stakeholders and suppliers to design, purchase, and build equipment and processes that meet the needs of NorthStar’s products, employees, and customers
2. Anticipate and troubleshoot process and procedural issues related to the manufacturing and packaging of Mo-99 and other radioisotopes as needed. Make tradeoffs between design complexity, time and effort, schedule, cost, and quality while meeting safety and regulatory demands.
3. Assist in the management of the operational teams involved in the radioisotope fill process at the NorthStar-Columbia operation.
4. Generate, edit, and issue master batch documentation (MBR’s) specific for the radioisotope fill process and related equipment and cleaning activities. Review executed batch documentation as needed.
5. Work with NorthStar’s QA team to investigate deviations and variances in both the manufacturing and packaging of Mo-99 source vessels; generate deviation reports and identify long term corrective and preventive actions. Assure implementation of such solutions in a timely manner.
6. Lead and assist in all technical process enhancements and ancillary activities related to radioisotope fill lines, such as but not limited to: process and equipment validation, implementation of new equipment, changes to existing manufacturing process, etc.
7. Investigate and provide support for scale-up batch manufacture, assist with engineering studies, and equipment upgrades including: specifying and buying new equipment, drafting operational procedures for equipment, writing and executing qualifications, and executing PM’s.
8. Identify and suggest process, equipment, and efficiency improvements for the radioisotope fill process.
Provide transition training to manufacturing personnel for introduction of new processes and manufacturing capability.
9. Work in cross-functional teams (Validation, QA, QC, SCM) to enhance and facilitate overall operational success.
10. Continuously adapt to an ever-changing regulatory environment such that the Company is in compliance with current regulations. Make adjustments to work plans accordingly.
11. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
12. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.
Ability and willingness to travel up to 20% 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/or EXPERIENCE
Bachelor’s degree in Chemical Engineering or other Engineering Discipline with a minimum of five years in a medical or pharmaceutical manufacturing environment; or equivalent combination of education and experience. Knowledge and skill in operation of scientific equipment is required. Knowledge of Product Development Life Cycle ranging from product specification and concept development to product release is desired. Must have demonstrable knowledge of FDA regulations in medical device/pharmaceutical environments. Experience with radioactive processing preferred.
Proficient knowledge of office software programs including Outlook, Word, Excel, Visio, and project planning.
While not having direct reports, this position must be able to train and instruct others and lead by example.
• 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