Commissioning & Qualification Consultant (Parenteral/Aseptic Process)

Validation & Engineering Group; Juncos (PR); On-site; Full time

Job summary

A consulting firm is looking for a Commissioning & Qualification Consultant to support the Validation and Qualification for parenteral manufacturing processes. Ideal candidates will have at least 8 years of experience in Commissioning & Qualification, be fully bilingual, and possess excellent technical writing skills. The position may require working different shifts and weekends. This role supports critical operations in the field of aseptic manufacturing.

Qualifications

• At least 8 years of experience in C&Q for Manufacturing Equipment and Process.
• Must have experience with aseptic filling process.
• Willing to execute validations on different shifts and weekends.

Responsibilities

• Support the Validation, Commissioning & Qualification for parenteral manufacturing.
• May also support Aseptic Filling Process, Media Fills, and Environmental Monitoring.

Skills

Technical writing

Bilingual (English/Spanish)

Education

Bachelor Degree in Engineering or Science

Job description

Overview

Commissioning & Qualification Consultant (Parenteral/Aseptic Process) - Full-time

Responsibilities

• 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 assigned projects.

Qualifications

• Bachelor Degree in Engineering or Science.
• REQUIRED: At least 8 years of experience in C&Q for Manufacturing Equipment and Process
• 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 Studies and/or Classified Room Performance Qualification, Aseptic filling, Environmental Monitoring.
• More positions available for Puerto Rico and USA.

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