Validation Engineer II
Validation Engineer II
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Job Description
Your Role:
As a member of the R&D Validation & Applications Center (VAC) Engineering team you actively participate on product development teams. Your contribution includes implementation of an efficient and thorough validation test matrix including development of new test equipment and test methods which ensures robust product performance specifications based on product design and intended applications. Your responsibilities include authoring the validation test protocol test and authoring the report. You participate in development of the product design specifications and risks assessments and coordinate testing for shelf life studies. You are responsible for planning documenting and executing test method validations. In addition you collaborate with Operations Product Management and Field Marketing to aid in product/process change requests raw material qualifications and customer applications. For VAC infrastructure you support test equipment and measurement systems which are utilized to characterize and validate new products including troubleshooting repairs and identifying and implementing equipment upgrades/new technology. You effectively interact with other groups such as R&D development teams Quality Engineering Services Facilities EHS and Finance.
Who You Are:
Minimum Qualifications:
- B.S. in Engineering or Applied Science or equivalent and 4 years of experience in process development or validation engineering
OR
- M.S. in Engineering or Applied Science or equivalent and 3 years of experience in process development or validation engineering
- 3 years of experience with process and product/system validations (IQ/OQ/PQ)
- 2 years of experience in equipment calibration troubleshooting and repairs
Preferred Qualifications:
- Experience with FMEA/risk analysis product failure and root cause analysis
- Experience authoring formal protocols and reports utilizingGood Documentation Practices.
- Experience with equipment design and development URS
- Experience with GAMP software validation plastics processing Capital Upgrades PLC and controls
- Working knowledge of quality principles including ISO Quality Management Systems
- Knowledge of applicable FDA Regulations USP requirements and other regulatory requirements (CB Scheme/ UL testing) for products and systems used in biopharmaceutical manufacturing processes
- Experienced with Product Development Process (PDP)
- Experience using statistical tools such as Gage R&R DOE capability analysis and data analysis in Minitab
- Familiarity with change control methodology
- Capable in the development and of test method validations
Employment Type
Full Time
