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Validation & Engineering Group

Life sciences validation and compliance consulting

Laboratory Validation Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeJuncos, Puerto RicoNo salary listed

About the Job

Requirements

  • Bachelor's degree in Chemistry or a related discipline.
  • Experience developing validation plans, risk assessments, IQ/OQ protocols, CSV IQ/OQ protocols, traceability matrices, validation reports, and operational and administrative standard operating procedures.
  • Validation experience with protein analyzers, UV analyzers, and viable and non-viable particle monitoring equipment.
  • Validation experience in computer systems.
  • Practical knowledge of 21 CFR Part 11.
  • Strong knowledge of Good Manufacturing Practices regulations.
  • Technical writing experience.
  • Validation expertise in sterilization, Kaye validators and data loggers, process validation, equipment qualification, re-qualification, and computer system validation.

Responsibilities

  • Develop and execute laboratory equipment validation.
  • Develop validation plans, risk assessments, IQ/OQ protocols, CSV IQ/OQ protocols, traceability matrices, validation reports, and operational and administrative standard operating procedures.
  • Execute related validation protocols.
  • Develop documentation packages for all activities, including original-format documents, approved documents, and applicable drawings.

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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