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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