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ATL01-092425 Validation Specialist - Laboratory CQV & Method Validation - GA
ATL01-092425 Validation Specialist - Laboratory CQV & Method Validation - GAZipRecruiter • Duluth, GA, US
ATL01-092425 Validation Specialist - Laboratory CQV & Method Validation - GA

ATL01-092425 Validation Specialist - Laboratory CQV & Method Validation - GA

ZipRecruiter • Duluth, GA, US
Hace 3 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Position Overview

We are seeking a skilled Validation Engineer to support a critical project at a manufacturing facility in Johns Creek, GA. The consultant will focus on laboratory equipment qualifications and analytical method validations to enable implementation of new products in production. This is a client-facing, hands-on role requiring strong technical expertise, attention to detail, and ability to work independently.

Location : Johns Creek, GA

Duration : October 20, 2025 – January 9, 2026

Commitment : Full-time (40–45 hours / week)

Key Responsibilities

  • Plan, author, and execute qualification protocols (IQ / OQ / PQ) for new laboratory instruments, including TruScans and balances
  • Develop and execute validation protocols for ~11 analytical methods (e.g., Gas Chromatography, UV-Vis Spectroscopy, Karl Fischer Titrations
  • Generate and revise validation documentation (protocols, reports, SOPs, specifications) in compliance with cGMP standards.
  • Conduct investigations for deviations, perform root cause analysis, and implement corrective actions.
  • Ensure compliance with Good Documentation Practices (GDP) and "right the first time" deliverables.
  • Collaborate with cross-functional teams (QA, Engineering, Production) and communicate project status to stakeholders.
  • Support change control management and risk assessment activities.

Required Qualifications

  • Bachelor's degree in Engineering, Chemistry, or related field.
  • 5–7 years of hands-on validation experience in pharmaceutical or medical device industries.
  • Proven expertise in laboratory equipment qualification and method validation.
  • Experience working with Kneat validation lifecycle management system (authoring, reviewing, approving, and archiving documents).
  • Familiarity with risk-based approaches to commissioning and qualification.
  • Strong technical writing, communication, and problem-solving skills.
  • Proficiency with Microsoft Word, Excel, and Project.
  • Ability to work independently and meet strict timelines.

    • Qualifications

  • Experience in computerized system validation (PLC, HMI).
  • Knowledge of medical device manufacturing (Class II).
  • Prior experience with contact lens production platforms.

    • Additional Information

  • Position requires onsite presence in Johns Creek, GA.
  • Contractor must complete required onboarding and training prior to project start.

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