Engineering Technical Analyst/WriterAn engineering technical analyst/writer who implements, supports, and manages practices and projects that improve quality, reliability, and efficiency. The position blends a working knowledge of equipment, processes, and management systems with an understanding of lean concepts to drive quality investigations and corrective actions associated to equipment and process, aimed to drive standardization, simplification, and efficiency into the culture. Essential Areas Of Responsibility Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Demonstrates a complete knowledge of manufacturing processes and equipment. Writes quality deviation reports and manages writes/edits change controls and CAPA's related to quality deviations and process improvements. Develops and interprets equipment reliability metrics. Leads problem solving / root cause analysis initiatives to eliminate defects and waste; leads implementation of subsequent preventive actions. Trains technicians and mechanics on lean concepts, zero loss culture, ownership culture, and equipment operating principles relevant to job function. Conducts and/or supports operator technical training. Tracks results and reports on quantifiable goals and objectives. Follows approved safety, health, and environmental policies and procedures. Other projects and duties as assigned.
Position Requirements:
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
3-5 years of experience on pharmaceutical industry or regulated environment. Experience writing quality investigations and CAPA execution associated to process equipment, facilities and utilities. Understanding of pharmaceutical processes. Experience with investigative tools and analyses such as RCA, FMEA, Ishikawa Fishbone Diagram, Pareto Chart, 5 Whys, Failure Mode and Effects Analysis (FMEA), Scatter Diagram, Affinity Diagram, Fault Tree Analysis (FTA), etc. Experience on using Computerized Maintenance Management Systems to pull and analyze data related to equipment maintenance and calibration plans, scheduling and execution. Six Sigma Green Belt a plus. Operational Excellence a plus.
Skills/Knowledge/Abilities:- Strong Organizational and multi-tasking skills. Demonstrates the ability to informally lead in a team based culture and work comfortably across all personnel levels.
- Understands manufacturing equipment, processes and technologies.
- Reading and ability to interpret blueprints and schematics.
- Ability to handle and manage multiple projects with minimal supervision.
- Proficient in computer applications including MS Office.
- Problem Solving:
- Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required.
- Perform and lead root cause analyses and quality investigations related to equipment and systems malfunctions.
- Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions.
- Normally provides general instruction on routine work and detailed instruction on new assignments to direct reports.
- May be asked to recommend methods and procedures for problem resolution.
Travel Requirements:
N/APhysical Requirements:
Standing for extended periods of time at work station or equipment.
Walking to move short distances quickly and frequently.
Sitting for extended periods of time at work station or mobile equipment.
Repetitive Motions - frequent motions of the wrists, hands and/or fingers.
Perform activities such as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.
May be required to wear personal protective equipment (PPE) as needed for assigned process (i.e. safety glasses, respirator, hearing protection, gloves, etc.).
