Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office
Job Description
This role will support manufacturing production through root cause analysis and implementing engineering solutions. The Engineer will identify and complete improvements to current manufacturing processes. Must uses the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project timelines and product costs.
A Day in the Life:
Lead problem solving efforts and issue resolution for major equipment breakdowns
Seek opportunities for process and optimization improvements not limited to throughput, yield, and containment.
Serve as primary point of contact as the equipment and process expert. Recommend capital investments and assist in new product development, product proposals, and quotes.
Analyze operational equipment and maintenance data to drive engineering solutions to support cost reduction, quality, safety, and operational efficiencies
Drive process improvements (PPI) with teams to complete PPI projects and cost savings initiatives
Work closely with maintenance to align on data driven decisions to improve equipment up time
Use root cause problem solving and CAPA generation and execution to improve quality
Collaborate with internal and external customers, as well as original equipment manufacturers to provide technical expertise, recommendations, and continuous improvement efforts on processing equipment
Communicate improvement ideas for the process and equipment performance to the department
Education:
Bachelor's Degree from an accredited College or University in Industrial, Manufacturing, Chemical, Mechanical engineering or related field is required.
Experience:
Minimum 1 year previous related experience in engineering, pharmaceutical manufacturing, and/or process equipment preferred.
Knowledge, Skills, Abilities:
Broad-based background in pharmaceutical manufacturing with a combination of experience and skills in one or more of the following areas: product/ process development, production support, engineering, validation or quality assurance preferred.
Self-starter with efficient work methods, analytical and problem solving skills and ability to balance multiple projects.
The individual should enjoy working in a fast paced environment and within a result-orientated team.
Able to express ideas and collaborate with multidisciplinary teams.
Innovative problem solver who can envision new and better ways of doing things.
Experience in an FDA regulated or regulated industry preferred.
