Under general supervision, responsible for all phases of medium-scale assigned process improvement projects, ensuring the successful conclusion of all phases within an appropriate time and at appropriate cost. Implements process improvements to meet quality standards, performs feasibility studies and solves problems. Creates necessary documentation and aides in communication to personnel.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
Provides technical process ownership to core manufacturing processes, further develops process methods, equipment, and support infrastructure to optimize production rates, efficiencies, yields, costs and quality performance.
Develop new manufacturing processes and assess the adequacy of equipment to meet ever changing market/manufacturing demands.
Identifies new equipment and technologies to support continuous improvement and capacity expansion of core capabilities. Design, validate and commission new production equipment and tooling, monitor modifications and upgrades, and troubleshoot existing processes.
Develops project budgets associated with the procurement of new equipment and technologies.
Ensuring planned engineering (process) progress with respect to the engineering deliverables for Tenders (as required) and awarded Projects, process engineering planning & scheduling, preparation of progress reports, manpower & resource forecasts, time schedules of engineers, utilization of resources effectively & efficiently.
Provides operational leadership by managing the Process Design & Detail Engineering including performing process simulations, design calculations, Process Optimization, sizing & selection of equipments etc. Review of Clients tender documents, specifications, datasheets, installation, start-up and validation of new process equipment and technologies.
Interacts with customers, internal team members and vendors to develop process and equipment specifications. Prepares qualification reports, flow diagrams, and charts on research data and information.
Implements and maintains appropriate engineering records consistent with cGMP and ISO regulations for production of Life Science biochemicals and reagents. Develops plans for the installation, movement, repair of equipment and utilities within the building.
Develop and own asset identification system for all manufacturing equipment.
Develop, implement and sustain reliability best practices to reduce unscheduled maintenance downtime and costs. Work closely with engineers/production staff. quality staff to monitor and improve the efficiency, output and safety of the plant
Optimize preventative and predictive maintenance programs, including Safety, Environmental, and Quality critical process control.
Analyze downtime to identify chronic/sporadic failures and lead reliability improvement efforts. Making observations and taking measurements directly, as well as collecting and interpreting data from the other technical and operating staff involved.
Lead RCFE (Root Cause Failure Elimination) process to identify root cause and implement corrective actions to prevent recurrence ensuring that all aspects of an operation or process meet specified regulations.
Development and utilization of key reliability metrics to consistently measure performance.
Provide long-range planning for the facility and equipment needs, including capital and major repairs. Support manufacturing and maintenance efforts as needed by the operation.
Develop engineering scope for equipment and review for input into Computerize Maintenance Management System CMMS. Manage multiple projects as deemed necessary based on requirements.
Performs other duties as assigned.
QUALIFICATIONS (Education/Training, Experience and Certifications)
Bachelor’s degree; MS or advanced education in mechanical, chemical or industrial engineering preferred
Minimum of 7-10 years of working experience in a manufacturing environment, in an engineering capacity involving chemical process design, transfer design input for manufacturability and capital funds request preparation; hands on involvement required
Applied engineering experience in a GMP manufacturing environment preferred
Familiar with purified water systems, blending/drying process technologies, evaporation purification systems and aseptic processing systems a plus
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
Must possess excellent communication and problem solving skills, be detail oriented, and flexible to work on multiple projects simultaneously
Proficiency in Microsoft Suite, CAD and/or Solid Works preferred
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.
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