Participate in the design, installation, start-up, operation, maintenance, or ongoing improvement of bio-manufacturing and pharmaceutical manufacturing processes and facilities.
Develop Functional Requirement Specifications (FRS) from design P&IDs for new processes; Design, specification, and procurement of equipment; Technical transfer of processes from development into commercial scale production; Training of production personnel associated with new process transfer; Collaboration with manufacturing support groups in the planning, reviewing, performance, and scheduling of activities related to start up of new processes; Support equipment installation, start-up, and validation activities.
Essential Duties and Responsibilities:
Advises on commitment of resources (cost and schedule). Designs and develops sequence, layout, and arrangement of operations necessary for a project (new process, process scale-up, or revision to existing process). All designs are created with a number of factors in mind, including: Incorporate GMP principles, Develop everything so that it is feasible, robust, and within budget and Design for waste management minimization. Creates blueprints, P&IDs, and process flow diagrams. Simulates process operations on computer. Calculates material/energy balances. Designs, specifies, and procures equipment as well as investigating alternative equipment configuration of existing equipment. Develops Functional Requirement Specifications (FRS) from design P&IDs for new processes. Develops user requirements for new processes. Develops CIP or SIP protocols for new processes. Scales up the process to pilot and manufacturing scale. Conducts safety or HAZOP (hazard and operability) reviews of a process in order to identify potential hazards and operability problems caused by deviations from the design intent of both new and existing process plants.
Manages installation, validation, and start-up activities. Writes and submits change control documents. Assists in developing and executing Commissioning/Qualification/and Validation protocols for new equipment. Typical protocols include: Factory acceptance test (FAT) procedures, Validation master plan System-commissioning protocols & Validation protocols Installation qualification (IQ), Operation qualification (OQ) and Performance qualification (PQ) Determines and orders raw materials for commissioning and validation. Identifies alternate vendors/suppliers. Writes operation qualification and process qualification test plans. Performs dry runs of automation sequences (Site Acceptance Testing or SAT). Performs equipment qualification protocols including automation control. Writes SOPs for equipment operation. Walks down P&IDs and isometric drawings for installation verification and drawing accuracy. Develops batch records. Develops preventive maintenance (PM) and calibration schedules. Creates and revises construction punch lists. Signs-off and accepts facility and equipment. Performs start-up training on equipment. Determines spare parts requirements.
Collaborates with manufacturing support groups such as Operations, Validation, Engineering/Facilities Engineering Services, and Instrumentation/Calibration Services in the planning, reviewing, performance, and scheduling of activities related to start up of new processes and support of existing processes. Supports and defines PVRs (Process Validation Runs). Investigates process, equipment, and automation deviations (ongoing troubleshooting). Performs process improvement functions including: bottleneck analysis activities to improve robustness technology transfer from process development Performs activities related to process control such as data trending, maintenance and automation changes, and control scheme updates, and monitors product quality (e.g. particle-size distribution of a granulated product). Performs activities related to change control such as identifying potential change, design and pre-approval of changes, implementation, required regulatory submissions, validation, and ROI analysis. Performs activities related to shutdown (and subsequent startup). Assists in emergency maintenance and monitors frequent/repeat maintenance repairs. Designs experiments to optimize and improve the process.
Intermediate Project Management Skills & Practices Organizes and manages large and/or complex projects to ensure efficient use of resources and effectively deliver results that meet or exceed expectations. Is also able to prioritize and coordinate multiple priorities simultaneously. Recommends total plan contingencies and alternatives to achieve project (technical and economic) objectives for their discipline. Manages and/or supports cross-functional teams. Writes proposals, reports, and regulatory submission packages for projects. Determines solutions to technical problems. Secures and protects intellectual property.
Education and/or Experience
BS in Chemical Engineering Minimum of 5 years of related experience in process improvement Experience in cGMP regulated facilities required Experience in FMEA is required
Six Sigma experience Green Belt certification Experience using Lean tools
Corning is the world leader in specialty glass and ceramics, creating and manufacturing keystone components that enable high-technology systems.
Corning’s history is filled with breakthrough technologies that have played an important role in the way the world works. We thrive on solving difficult, commercially relevant problems through an innovative and collaborative research and development process. Corning succeeds through sustained investment in R&D, more than 160 years of materials science and process engineering knowledge, and a distinctive collaborative culture.
Corning Life Sciences brings new and innovative laboratory tools to researchers. Our core technical competencies include polymer science, biochemistry and molecular biology, glass melting and forming, surface modification, and characterization science. As part of Corning Incorporated, we are a world leader in specialty glass and have a 150-year tradition of innovation.
We are committed to meeting customers’ unique and changing needs with original solutions for today’s emerging life sciences technologies. Our dedication to quality, technology and innovation has enabled us to produce the world’s most comprehensive line of laboratory tools for life science research. Corning Life Sciences also offers custom capabilities such as special packaging, bar coding, and printed lot numbers, to meet specific customer requirements
To know more about Corning Life Sciences, visit us at: http://www.corning.com/products_services/life_sciences.aspx
Monster - 18 months ago
Corning Incorporated is the world leader in specialty glass and ceramics. Drawing on more than 160 years of materials science and process...