04 May, 2021

Process Improvement Engineer

  • Thermo Fisher Scientific
  • Cincinnati, OH, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

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?

  • Education
  • Bachelor’s Degree in Engineering or Related Field is required.

 

  • Experience
  • 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

Apply Now