Biomerieux , Inc.
Production Compliance Engineer
At a glance
Location: US-MO-St. Louis, MO, United States Map
Posted: 12/06/2018
Closing: 01/05/2019
Degree: 4 Year Degree
Type: Full-Time
Experience: 2 to 3 years
Biomerieux , Inc.
Job description
A strong Scientific and technological pioneering spirit drives bioMérieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioMérieux commitment to public health. bioMérieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products. We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.

A strong Scientific and technological pioneering spirit drives bioMérieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioMérieux commitment to public health. bioMérieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products. We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities. Primary Purpose and Overall Objective of the Job: The Compliance Engineer is primarily responsible for troubleshooting equipment and/or process related issues, writing and completing Non Conformity Investigation Reports (NIR) and CAPAs, initiating and overseeing change control activities, supporting customer complaint responses as needed, writing and revising SOPs and Manufacturing Directions (MD), evaluating and recommending new equipment purchases and providing input to internal and external audits. Responsible for identifying improvement opportunities and implementing changes to improve products, processes and/or reduce costs through the use of lean manufacturing techniques and other tools. Execution and direct management of improvement projects within the Operations and Quality functions through training, cross functional team facilitation, and project completion to achieve the required results. Project accountability from conception to completion. Tracks project status, audits results and presents updates to senior management. Main Accountabilities Write and complete Non Conformity Investigation Reports. Troubleshoot non conformities in manufacturing areas. Utilize investigation tools such as Fishbone, IS/IS NOT and 5 Whys to identify investigation scope, true cause and product impact. Write Investigational CAPAs and complete CAPA actions items. Initiate and manage department related change controls Support department activities related to customer complaints Work to address miscellaneous quality-related issues. Write and/or review Standard Operating Procedures to ensure they comply with current Good Manufacturing Practices. Develop reports utilizing statistical tools identifying and trending KPIs. Participate in investigation of vendor quality issues

Studies-Experience: * BA/BS degree, preferably in a science related field. * 2 to 4 years experience working in Operational roles and driving improvements. In-depth knowledge of Manufacturing Processes. Experience in FDA regulated environment desired. * Experience in root cause analysis * Lean manufacturing experience to include leading and facilitating continuous improvement initiatives (Kaizen, 5S, set-up reduction -SMED-, etc.) is desired. * Lean Six Sigma certification highly desired. * Demonstrated strengths in leadership, interpersonal skills, project management, creative thinking, problem solving, and the development of manufacturing systems and their deployment. * Computer skills required, including Microsoft Word, Excel, PowerPoint, Outlook and ability to learn local quality system software. Skills and Qualifications: * Excellent verbal and written communication skills. Ability to clearly communicate with bioMerieux departments * Good organizational skills and the ability to coordinate multiple activities. * Must be able to work effectively in a team based environment. * Reasonable, reliable attendance and punctuality are essential features required for this position. bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity.
Production Compliance Engineer