Thermo Fisher Scientific Process Improvement Engineer in Cincinnati, Ohio
How will you make an impact?
Responsible for leading department quality investigations to determine root cause and both corrective & preventative actions for top quality losses. Proactively leads quality improvements for the department
What will you do?
Responsible for conducting investigations of production related deviations of batches, preps, lots, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and customer requirements are met.
Lead the quality response process including initial response, containment, root cause investigation and determining appropriate corrective & preventive actions
Writes investigation reports in Trackwise (Quality System).
Responsible for leading huddle process to achieve timely deviation and action closure to meet departmental goals
Proactively drives quality improvements to achieve department right first time (RFT) and quality compliance goals.
Participates in inspection readiness activities and may also be involved in audits and inspections by regulatory agencies.
Models effective and constructive communication and interactions with technical departments both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
Requires a passion for problem solving, attention to detail, good organizational skills, a sound understanding of cGMPs and Manufacturing/ Packaging.
Requires interaction with the operations personnel, QA GMP Services, Process Engineers, Records/Release, Quality Control, QA Regulatory, Engineering, and Clients.
Position requires flexibility at times to complete interviews/investigations with night and end of week shifts. Escalates critical events and investigation findings to Production and Quality Assurance Management.
May represent the production department on various project teams such as validation, engineering phase review meetings, and daily department communication meetings.
May also assist in developing and maintaining various quality and training systems and programs.
How will you get here?
Bachelor's Degree in Engineering or Related Field is required.
Quality, process and manufacturing investigation and technical writing experience is desired
Equivalent combinations of education, training, and relevant work experience may be considered
Knowledge, Skills, Abilities
Background in cGMP's requirements
Lean Six Sigma problem solving skills
Experience writing technical reports
Must be able to manage and prioritize daily tasks with minimal supervision
Microsoft Office Word, Excel and PowerPoint
Must be able to learn and navigate through investigation, quality and ERP systems
Have flexibility to work various shifts times if needed to complete work content.
Ability to influence change and manage multiple projects
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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