Supports manufacturing production through troubleshooting to determine root cause and possible engineering solutions. Identify and implement improvements around current manufacturing processes. Executes the innovation and development of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacture of new products. Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs
- Support troubleshooting and issue resolution for major equipment breakdowns
- Identifies opportunities for process and optimization improvements not limited to throughput, yield, containment, and cost savings.
- Serve as primary point of contact as the equipment and process subject matter expert for requests outside of operations to support capital equipment investments, 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.
- Provide engineering support for new product and process introductions
- Assist in selection components for capital equipment investments
- Drive PPI mindset with teams to identify and execute on PPI projects and cost savings initiatives
- Work closely with maintenance and reliability to align on data driven decisions to improve equipment up time
- Root cause problem solving and CAPA generation and execution to improve quality
- Capable of interfacing with customers and external clients to explain technical challenges and propose solutions
- Collaborates with internal and external customers, as well as original equipment manufacturers to provide technical expertise, recommendations, and continuous improvement efforts on processing equipment
- Communicates process and equipment performance to the department, identifying opportunities and proposals
- Conducts risk assessments and collaborates closely with the maintenance and reliability teams
Bachelor’s Degree in Engineering (industrial, manufacturing, chemical, electrical and mechanical engineering)
- 2+ years previous related experience in engineering, pharmaceutical manufacturing, and process equipment
Equivalent combinations of education, training, and relevant work experience may be considered.
- Strong leadership, planning and time management,
- The desire to progress, learn, grow, and succeed.
- Advocate for change and process improvements
- Working knowledge of related pharmaceutical equipment
- Ability to approach tasks and projects with a sense of urgency
- Able to work effectively with OEMs to troubleshoot and order parts
- Capable of working cross functionally and adjusting priorities to fit the business need
- 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.
- Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
- The individual should enjoy working in a fast paced, dynamic and results orientated team environment.
- Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.
- Innovative thinker - should be able to envisage new and better ways of doing things.
- Excellent data analytical skills, ability to plan, organize and implement concurrent tasks.
- Experience in an FDA regulated or regulated industry beneficial.
- High level of PC Skills required.
- Excellent attention to detail.