Engineer 2, Process Development
This individual will provide technical leadership to new product introduction, production process development, improvement and sustaining efforts. Additionally, these teams will partner cross-functionally with R & D, Quality, Production and other engineering groups to develop processes for new products and sustain and improve processes for existing products.
- Participate in process development, definition and improvement, and other activities in the making of consumable products or support of processes/equipment used to sequence genomes.
- Work in cross-functional teams to both (1) represent operational needs and (2) develop and transfer new processes/products to production and/or to enhance existing processes/products in production.
- Construct and execute controlled experiments to screen, optimize, and scale chromatographic and synthetic chemistry processes.
- Develop assessments and strategies for identifying, managing, and reducing product / process risk utilizing a variety of techniques including FMEAs, DOEs, and Control Plans.
- Manage process capability in respect to the overall needs of the end sequencing product(s), driving a solutions based approach to address yield and quality issues in a regulated production environment.
- Troubleshoot new and existing product or process issues related to yield, quality and throughput, utilizing structured problem solving techniques and quality assurance mechanisms when appropriate (e.g. 8D, A3, and CAPA)
- Analyze process test results, issue reports and make technical recommendations.
- Manage small to medium size projects for process improvements and technology transfers
- Develop technical summaries and provide assistance for regulatory filings
- Author technical documents including batch records, SOPs, engineering / development reports, and risk / validation assessments.
- Act as a subject matter expert, mentoring less experienced members of the team and providing training / guidance to manufacturing staff and other members of the organization
- Work experience in the biotech, pharmaceutical or semiconductor industries is desirable
- Experience working in an ISO13485 or FDA certified environment is desirable.
- Experience in high-volume production in a high-tech consumables industry is a plus.
- High level computer skills are required. Intermediate level programming knowledge is a plus.
- Experience with chromatographic processes (e.g. IEX, RP, HIC, and SEC) is a plus.
- Experience with Process Validation and Quality by Design (QbD) experience is a plus
- Experience in production support and/or process development is required.
- Experience with statistics, Statistical Process Control and DOE techniques is required.
- Experience developing risk management and process control strategies is required.
- High level problem solving and reasoning skills are required.
- Experience with product development processes and project management skills is required.
- Demonstrated ability to accomplish goals while working across departments is required.
- Good interdepartmental communication skills and documentation skills are required.
- MS/PhD in Organic Chemistry, Analytical Chemistry, or B.S./M.S./ PhD in Chemical Engineering, Biochemical Engineering with at least 4 years of relevant experience in production support/sustaining and/or process definition and development, design, scale-up, improvement and validation.