Commissioning & Qualification Consultant (Parenteral/Aseptic Process)
Validation & Engineering GroupPuerto Rico, United States
Posted January 12, 2021
Full Time
About the Company
Validation & Engineering Group provides compliance, validation, and engineering services for pharmaceutical, medical device, and biotech companies.
Job Description
Support the Validation, Commissioning & Qualification for parenteral manufacturing process and equipment in the assigned project(s). May also, support Aseptic Filling Process, Media Fills, Environmental Monitoring and other assign projects.
Requirements
- Bachelor Degree in Engineering or Science
- At least 8 years of experience in C&Q for Manufacturing Equipment and Process
- Fully bilingual (MUST)
- Excellent technical writing
- Willing to execute validations on different shifts and weekends
- Experience with aseptic filling process (parenterals manufacturing, sterile products filling process)
- Experience with Process Validation, Media Fills, Smoke Profiles and/or Classified Room Performance Qualification, Aseptic filling, Environmental Monitoring