Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or related field.
• 5+ years of validation experience in a GMP-regulated environment.
• Expertise in IQ/OQ/PQ, Process Validation, Equipment Qualification, Cleaning Validation, and Computer System Validation (CSV).
• Familiarity with FDA, EMA, 21 CFR Part 11, and GAMP 5 guidelines.
• Excellent technical writing and documentation skills.

Responsibilities

• Lead validation lifecycle activities including DQ, IQ, OQ, and PQ.
• Author, review, and approve validation protocols and reports.
• Execute validation activities for equipment, processes, and systems.
• Support commissioning and qualification activities for new equipment.
• Manage deviations, investigations, CAPAs, and change controls related to validation.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, GxP, and data integrity requirements.
• Support regulatory inspections and audits.
• Collaborate with Engineering, Quality Assurance, and Regulatory teams.
• Mentor junior validation engineers and specialists.

Benefits

• Collaborative environment that encourages mentorship and professional growth.
• Opportunity to enhance compliance with a focus on FDA and EMA regulations.
• Engagement with cutting-edge validation tools and methodologies.
• Involvement in regulatory inspections and internal audits.
• Contribution to the development of critical validation documentation and processes.