Large pharmaceutical manufacturer has an immediate need in Opeika, AL for a Quality/Validation Engineer to support manufacturing process validation activities on a recently upgraded automated plant. This is a contract opportunity expected to last 1 year could be longer based on performance, possible temp to perm. Apply Now!
Responsibilities for the Quality Engineer
- Responsible for implementing process validation and Statistical Process Control (SPC)-designing, developing, implementing validation protocols, FMEAs and Specifications
- Work within a specified team to create Process FMEAs, CQAs and CPPs.
- Site expert leading the implementation of new manufacturing specifications and SPC utilizing a selected electronic Tool
- Support the global team in the validation and verification of the SPC tool
Requirements for the Quality Engineer
- BS in Engineering, Mechanical or Biomedical preferred
- 1-3 years experience in process validation, preferably within the medical device industry
- FMEA-Failure modes and effects analysis knowledge
- CQA -Critical Quality Attributes knowledge