Chemical Process Engineer II
This position will assist the product and process development teams with creation and implementation of simple to complex manufacturing process designs in compliance with cGMP regulations. This position will be responsible for defining and creating new procedures for documenting or qualifying equipment/processing which can be transitioned to manufacturing production engineering team members. 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. Specify new equipment, implement solutions to complex requirements and create fixtures to support manufacturing processes in accordance to cGMP regulations.
2. 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.
3. Provide transition training to manufacturing personnel for introduction of new processes and manufacturing capability.
4. Anticipate and mitigate risk points. Make tradeoffs between design complexity, time and effort, schedule, cost and quality while meeting safety and regulatory demands.
5. Interpret detailed engineering drawings.
6. Investigate, recommend and assist with design implementation and manufacturing process decisions to maximize internal expertise and productivity.
7. Continuously adapt to an ever-changing regulatory environment such that the Company is in compliance with current regulations. Make adjustments to work plans accordingly.
8. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
9. 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 and three to five years of experience in a medical device 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.
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.