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Commissioning & Qualification Consultant (Parenteral/Aseptic Process)Validation & Engineering Group

Commissioning & Qualification Consultant (Parenteral/Aseptic Process)

Juncos, Puerto RicoOn-siteFull-time

AI Summary

Supports validation, commissioning, and qualification of parenteral manufacturing processes and equipment, including aseptic filling, media fills, and environmental monitoring for pharmaceutical and biotech projects.

About this role

Commissioning & Qualification Consultant (Parenteral/Aseptic Process)

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services.

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.

Qualifications

  • Bachelor Degree in Engineering or Science.
  • REQUIRED: At least 8 years of experience in C&Q for Manufacturing Equipment and Process
  • CSV Experience a plus
  • Fully bilingual (MUST)
  • Must have: Excellent technical writing; Willing to execute validations on different shifts and weekends.
  • Must have: Experience with aseptic filling process (parenterals manufacturing, sterile products filling process)
  • Must have at least one of the following: Experience with Process Validation, Media Fills, Smoke Profiles and/or Classified Room Performance Qualification, Aseptic filling, Environmental Monitoring.

Additional Information

More Positions available for Puerto Rico and USA.

Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

Skills

Aseptic FillingClassified Room Performance QualificationCommissioning & QualificationCSVEnvironmental MonitoringMedia FillsParenteral ManufacturingProcess ValidationSmoke ProfilesTechnical Writing

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