Requisition Number 19-0247
Post Date 9/18/2019
Title Continuous Improvement Engineer
The Continuous Improvement own the entire trial request process, compliance initiatives for validation, support waste reduction, oversee deviations, change controls and hold investigations on assigned Value Stream. In addition, this position will support
continuous improvement of an FDA and ISO-compliant quality system that conforms to the Nice-Pak Quality Manual.
ESSENTIAL FUNCTIONS AND BASIC DUTIES:
The Continuous Improvement Engineer will interface with Production, R&D, Warehouse, Management, Supervision, Corporate, sister manufacturing sites in the US and overseas and vendors.
Manage the trial request process (operational qualification)
Review the trial request form for accuracy as they are submitted
Upon receipt of Trial Request items, schedule a time for Trial Request to be executed on the production line(s).
Inform Production Supervisors and Managers (manning, date, line, and documents pertaining to Trial Request, as well as data collection sheets), Warehouse (materials required), Engineering (support on line, especially if running a new product), Maintenance
(support on line), Supply (materials required).
Determine process capability and generate final trial outcome report.
Determine and write deviations as required for production
New Product launch details in place and maintained
Participate in Continuous Improvement initiatives, supports Operational Excellence efforts throughout the facilities.
Support production in investigations of product non conformances
Ensure that deviations are in place when needed, provide monthly deviation reports
Determine root cause of variability in all key processes
Perform risk assessment of manufacturing processes to determine the need for and extent of validation
Work with engineering to define validation completion and change control performance measures, and implement subsequent trending for change post mortem
Manage validation requirements in compliance to cGMP and site mater validation plan.
Ensure that documented evidence is provided, demonstrating that product can consistently meet release criteria
Ensure compatibility between process capability and Finished Product Specifications
Ensure required records are adequately defined, completed and archived.
Support internal and external customer
Support line with trouble shooting and investigation to root cause with raw material concerns or defects
Responsible for impact assessment on validation through the change control process.
All other duties as assigned
Associate or bachelor’s degree in engineering, Science, Mathematics or equivalent experience. ASQ certification preferred.
Proficient at using Microsoft Office and statistical analysis software. Functional experience working in a fast pace, time sensitive, environment.
Strong organizational skills.
Statistical process control knowledge or experience.
Knowledge of ISO requirements
Knowledge of Problem Solving tools (Process Mapping Risk Analysis, Cause & Effect Diagrams or Pareto Analysis) PFMEA
0-3 years of Quality or Manufacturing experience preferred. Six Sigma lean manufacturing skills a plus.
Strong attention to detail skills.
Strong leadership skills.
Strong communication and presentation skills.
Strong Computer and Information Technology skills (MS Work, MS Excel, MS Access, MS Power Point or equivalent, Visio or equivalent, MS Project, statistical software usage and principles, Database Management, MiniTab).
Good verbal and written communication skills demonstrated by the ability to generate technical reports.
Must work independently and in a strong team environment.
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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
Please view Equal Employment Opportunity Posters provided by OFCCP
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access
to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure
is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41
Please refer to the Company’s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
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