Validation Engineer

Role Overview:

We are seeking an Intermediate Validation Engineer to join our team and support validation activities across manufacturing systems, equipment, and processes. The ideal candidate will have at least four years’ experience in engineering validation, preferably in the pharmaceutical, biotech, medical device, or industrial sectors. You will be responsible for executing and documenting validation tasks, ensuring compliance with regulatory requirements.

Key Responsibilities:

• Plan, execute, and document validation studies for equipment, utilities, manufacturing processes, and computer systems (CSV, as applicable).
• Prepare, review, and update validation protocols, reports, and related technical documentation.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) activities.
• Collaborate with engineering, QA, and production teams to ensure smooth validation project execution.
• Investigate validation failures and deviations, assist with root cause analysis and CAPA implementation.
• Maintain compliance with GMP, FDA, ISO, and other relevant regulatory standards.
• Analyze test data and summarize findings, recommending improvements as needed.
• Participate in audits, inspections, and contribute to inspection readiness.
• Support process and equipment changes, ensuring re-validation as required.

Requirements:

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or related field), Life Sciences, or similar.
• Minimum 4 years’ experience in validation engineering or related roles within regulated manufacturing environments.
• Knowledge of validation lifecycle, regulatory compliance (GMP, FDA, ISO 13485, etc.), and industry best practices.
• Strong analytical, problem-solving, and documentation skills.
• Experience with validation of instruments, equipment, and processes.
• Ability to work effectively in cross-functional teams and manage multiple projects.