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LL01-081924 Validation Specialist for API Manufacturing

2 months ago

Duluth, United States Validation & Engineering Group Full time
Job DescriptionJob Description

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

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Validation Specialist for API Manufacturing

Qualifications:

  • Bachelor's Degree in Science or Engineering.
  • Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
  • Experience in API process development and scale-up.
  • Knowledge of Quality by Design (QbD) principles.
  • Experience with validation of automated control systems and software.
  • Must be proficient using MS Windows and Microsoft Office applications.
  • Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
  • Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.

  • Excellent written and verbal communication skills, with the ability to effectively document and present validation findings.

  • Attention to Detail: High level of attention to detail and commitment to quality.

  • SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
  • Strong knowledge (according to related area).
  • Technical Writing skills and investigations processes.
  • Available to work extended hours, possibility of weekends and holidays.