Accessibility Links

Process Engineer/Quality Engineer

  • Job type: Permanent
  • Location: Austin
  • Salary: Competitive
  • Job reference: EPM
  • Sector: EPM Scientific, Quality
  • Date posted: 12/12/2017

Job Requirements

Experience with harvesting cells from tissue

Experience conducting cell-based assays 

Familiarity with quality systems and documentation,cGMP practices, and FDA requirements

Ability to discover and interpret relevant technical literature

Ability to apply engineering principles and statistical analysis, including design of experiments, in order to
solve processing issues and evaluate opportunities for process improvements

Duties

Design and conduct experiments for human cell isolation and culture process optimization 

Assist in designing requirements for and performing product verification and validation testing

Conduct technical assessments on process/product impact due to changes in equipment, scale, and raw materials and develop appropriate quality tests and standards.

Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products 

Appropriately document experiment plans and results, including protocol writing and reports

Provide process development and quality engineering support to manufacturing operations

Document, analyze, and present results



Similar jobs
Lead Auditor
  • Job type: Permanent
  • Location: Amsterdam
  • Salary: Competitive
  • Description Lead Auditor: I am currently working on a project with a rapidly developing Global Notified body who are going through a growth phase following several...
Quality Manager
  • Job type: Permanent
  • Location: Ireland
  • Salary: Competitive
  • Description Quality Manager: A dynamic Pharmaceutical company is seeking an experienced Quality Manager for their site in Ireland. The manager will have five direct reports and...
Senior Quality Risk Manager
  • Job type: Permanent
  • Location: Ireland
  • Salary: Competitive
  • Description The Job: A Leading Biotechnology company is seeking an experienced ‘Senior Quality Risk Manager’ based in Ireland, Limerick. This is a senior position
Quality Vice President
  • Job type: Permanent
  • Location: Munich
  • Salary: £110000 - £115000 per annum
  • Description Job Description: A global Notified Body is seeking an experienced Quality Vice President (QVP) based in Germany. The QVP will act as the lead auditor...
Senior Quality Manager
  • Job type: Permanent
  • Location: Ireland
  • Salary: Competitive
  • Description Senior Quality Manager: A dynamic Pharmaceutical Biologics company is seeking a Senior Quality Manager who is well experienced in Risk Management for their up and...