Parenteral Aseptic CQ Consultant — Validation Expert

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

Commissioning & Qualification Consultant (Parenteral/Aseptic Process)

• Full-time

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.

• 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 Profiles and/or Classified Room Performance Qualification, Aseptic filling, Environmental Monitoring.

More Positions availablefor Puerto Rico and USA.

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

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