Job Title Synonyms

Job Description

Job Summary:

The Validation Engineer (Biotechnology) is responsible for ensuring that all equipment, systems, utilities, and manufacturing processes used in biopharmaceutical production operate in compliance with cGMP and regulatory requirements. This role supports commissioning, qualification, validation (CQV), and continuous improvement initiatives across upstream, downstream, and aseptic processing environments.

Key Responsibilities:

• Execute and document validation activities including IQ/OQ/PQ for equipment, utilities, and automated systems used in biotech manufacturing.
• Support process validation, cleaning validation, and method validation in accordance with FDA, EMA, and ICH guidelines.
• Prepare validation protocols, reports, risk assessments, and related documentation aligned with cGMP and company procedures.
• Collaborate with Manufacturing, Quality, Engineering, and R&D to ensure smooth technology transfer and validated process performance.
• Participate in change control, deviation investigations, CAPA, and continuous improvement initiatives.
• Ensure compliance with regulatory expectations during equipment commissioning and qualification.
• Maintain validation documentation and ensure readiness for audits and inspections.
• Support validation of single-use systems, bioreactors, chromatography skids, filtration systems, and cleanroom environments.

Qualifications:

• Bachelor’s degree in biotechnology, Chemical Engineering, Biomedical Engineering, or related field.
• 1–5 years of validation or CQV experience in the biotech or biopharma industry.
• Knowledge of cGMP, FDA 21 CFR Part 210/211, Annex 1, ICH Q7–Q10.
• Experience with equipment qualification, process validation, and technical documentation.
• Strong analytical, organizational, and communication skills.