Freelance Lead Validation Engineer

Freelance Lead Validation Engineer.

Freelance Lead Validation Engineer

Texas

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Contract

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Manufacturing, Packaging & Production

Main Responsibilities

  • Develop or modify validation packages and deliverables (assessments, plans, requirements, protocols).
  • Report unexpected validation events or issues to project team and management.
  • Use systematic problem-solving to resolve validation issues.
  • Oversee and approve equipment, process, and validation documentation and change control records.
  • Ensure documentation accuracy, clarity, consistency, completeness, and compliance.
  • Drive FUE and process validation strategies for new or modified products, processes, facilities, and equipment.
  • Incorporate procedures, controls, and recovery plans into implementations/changes.
  • Collaborate with cross-functional teams to ensure quality and compliance.
  • Meet validation schedules aligned with project goals.
  • Work independently with objectives from the Quality Manager.
  • Plan and coordinate work per higher-level project schedules.
  • Support investigations and resolution of product/process nonconformances and CAPA.
  • Identify and support process improvement opportunities.
  • Provide coaching and mentoring to team members and colleagues.
  • Participate in or lead quality teams and support divisional initiatives.
  • Perform other related duties as assigned.

Qualifications

  • Education: Bachelor's Degree in Engineering or Technical Field, or equivalent education and work experience.
  • Experience:
    • Minimum 5 years in medical device/pharmaceutical manufacturing.
    • Process Validation and use of Quality tools/methodologies.
    • Knowledge of FDA, GMP, ISO 13485, and ISO 14971.
  • Skills:
    • Strong written and oral communication.
    • Project management and leadership.
    • Medical device validation (preferred).
    • Implementation of product/process improvement (Six Sigma, Lean Manufacturing).
    • Teamwork and individual contribution in fast-paced environments.
    • Effective communication at multiple organizational levels.
    • Multitasking, prioritization, and meeting deadlines.
    • Organizational skills and attention to detail.
    • Regular and predictable attendance.

Please send your resume to James.Gregory@darwinrecruitment.com

Darwin Recruitment is acting as an Employment Business in relation to this vacancy.

James Gregory

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