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API Manufacturing Validation Expert

2 months ago

Duluth, Georgia, United States Validation & Engineering Group Full time
Position Overview

Validation & Engineering Group, Inc. (V&EG) stands at the forefront of providing essential services across various sectors including Pharmaceuticals, Biotechnology, Chemicals, Food, and Medical Devices. Our expertise spans Laboratory Services, Compliance, Engineering, Project Management, and Validation among others.

We are currently in search of a dedicated and skilled professional to fulfill the role of:

Validation Specialist for API Manufacturing

Key Responsibilities:

  • Conduct validation activities related to API manufacturing processes.
  • Ensure compliance with industry standards and regulatory requirements.
  • Develop and execute validation protocols including IQ, OQ, and PQ.
  • Document validation findings with precision and clarity.

Qualifications:

  • Bachelor's Degree in a relevant field such as Science or Engineering.
  • A minimum of 3 years of experience in the pharmaceutical, medical device, or biotechnology sectors.
  • Proven experience in API process development and scale-up methodologies.
  • Familiarity with Quality by Design (QbD) principles.
  • Experience in validating automated control systems and associated software.
  • Proficient in MS Windows and Microsoft Office Suite.
  • Strong understanding of cGxP regulations and their application in compliance scenarios.
  • Experience in creating Design Documentation (URS, DS) and managing deviations and reports.
  • Exceptional written and verbal communication skills for effective documentation and presentation.
  • Meticulous attention to detail and a strong commitment to quality assurance.
  • Knowledge of SDLC, Risk Assessment, Data Integrity, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
  • Strong technical writing skills and experience in investigative processes.
  • Willingness to work extended hours, including potential weekends and holidays.