What are the responsibilities and job description for the Manufacturing Engineer - pharmaceutical position at Impact Solutions Inc?
As the Manufacturing Mix/Coat Engineer you will provide ongoing commercial process support, improvement, CI initiatives, equipment selection / support and scientific support to the portfolio of products that are in commercial and or transitioning into commercial across various industries. Support the portfolio of products and projects in accordance with cGMP, FDA, and DEA regulations and standards.
Education and Experience:
· Minimum of BS degree in science or engineering.
· Minimum 4 years of direct industry experience
· Meets all requirements of Engineer III level.
· Prefer 2 years hands-on experience in manufacturing process improvement / sustainability within the pharmaceutical industry, preferably with transdermal and oral dissolvable thin film products, OR, experience with pressure sensitive adhesive processes for medical or other applications.
· Ability to review large amounts of data/information, identify trends, draw conclusions and support a position with text and data.
· Proven track record of planning and executing process re-development/ CI projects, and an ability to meet aggressive timelines.
· Highly motivated individual who can work both independently and as part of a cross-functional team.
· Demonstrated problem-solving and analytical skills
· Strong organizational to handle multiple competing priorities in a fast-paced environment and complete required activities in a timely manner.
· Strong technical writing and oral communication skills. Must be able to effectively communicate results or issues, verbally and in writing.
· Knowledge and experience with cGMP for pharmaceuticals and QbD principles preferred.
· Knowledgeable and experienced with cGMP, USP and the regulatory requirements for pharmaceuticals.
