Validation & Engineering Group

Life sciences validation and compliance consulting

Commissioning & Qualification Consultant

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeNo salary listed

About the Job

Requirements

A bachelor's degree in Engineering or Science is required.
A minimum of 3 to 5 years of experience in commissioning and qualification for manufacturing equipment or facilities is required.
At least 3 to 5 years of experience in the pharmaceutical, biotechnology, or medical device industries is required.
Experience in Quality Systems is required.

Responsibilities

Serve as the focal point for Commissioning & Qualification and/or Computer System Validation in an assigned project.
Work on multidisciplinary engineering capital project teams and other project-related cross-functional teams with representatives from departments throughout the organization.
Manage assigned project goals within scope, on budget, and on schedule.
Communicate proactively with stakeholders and senior management about progress, issues, and plans for resolution.
Develop and execute Commissioning & Qualification/Computer System Validation strategies and validation documents.

Desired Qualifications

Computer System Validation experience is a plus.

Job Description

Serve as focal point for Commissioning & Qualification and/or Computer System Validation (CSV) in assigned project.
Work on multi-discipline engineering capital project teams, as well as other project-related, cross-functional teams with representatives from departments throughout the organization.
Manage assigned project goals within scope, on budget, and on schedule.
Communicate proactively with stakeholders and senior management regarding progress, issues, and plans for resolution.
Development and execution of C&Q/CSV Strategies and Validation Documents.

Qualifications

Bachelor Degree in Engineering or Science.
3 to 5 years of experience in C&Q for Manufacturing Equipment or Facilities
CSV Experience is a plus
Experiences in Quality Systems
Must have at least 3 to 5 years of experience in the the pharmaceutical, biotechnology or medical device industries.

Additional Information

Positions available for Puerto Rico.

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

About the Company

Validation & Engineering Group

Life sciences validation and compliance consulting

Validation & Engineering Group provides regulatory compliance and engineering consulting for life sciences clients in Puerto Rico and the USA, serving pharma, biotechnology, medical devices, and food sectors. It guides the full product lifecycle, performing commissioning and qualification, computer system, equipment, process, and cleaning validation, drafting quality systems, and ensuring regulatory compliance with FDA and European standards. The firm differentiates itself with hands-on engineering expertise combined with deep regulatory knowledge and broad geographic reach, now enhanced after joining Pinnaql Inc. through an acquisition by 3Boomerang Capital, with founders continuing as partners for continuity. Its goal is to help clients bring products to market faster and more reliably by sustaining GMP-compliant operations and ongoing lifecycle compliance.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Guaynabo, Puerto Rico
Founded: 1997

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