Validation Engineer

3 weeks ago

Cork, Cork, Ireland Blackfield Associates Full time

Validation Engineer – Job Description

Overview:

We are seeking a Validation Engineer to support new product introductions, equipment qualification, and site requalification activities. This role ensures equipment, systems, and processes remain compliant with cGMP and regulatory standards.

Key Responsibilities:

  • Plan, execute, and report on process and equipment validation activities.
  • Maintain validation documentation and ensure compliance with internal and regulatory standards.
  • Provide guidance on validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
  • Support change control and participate in regulatory inspections.

Requirements:

Experience:

  • 3–5 years in healthcare manufacturing; pharma experience preferred.

Skills:

  • Strong troubleshooting and project execution skills.
  • Knowledge of validation regulations (FDA, EU), GAMP, ISPE, and relevant guidelines.
  • Team player with excellent communication and problem-solving abilities.
  • Familiarity with quality systems and validation lifecycle management.

Education:

Degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering (Chemical, Mechanical, Electrical).

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