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Position Summary

Meet has partnered with a growing pharmaceutical manufacturing organization supporting sterile injectable and biopharmaceutical products. The company is seeking a Senior Validation Engineer to lead and execute validation activities across manufacturing operations.

This individual will ensure that facilities, utilities, equipment, computerized systems, and processes are designed, installed, qualified, and maintained in a validated state in compliance with FDA, EU GMP, ICH, and other global regulatory requirements. The role will also provide technical leadership and subject matter expertise in aseptic processing, cleanroom environments, and contamination control strategies.

Key Responsibilities

Validation & Qualification

• Lead and execute DQ, IQ, OQ, and PQ activities for aseptic filling lines and isolators/RABS, autoclaves, SIP/CIP systems, lyophilizers, sterile filtration systems, cleanrooms, and classified areas
• Author, review, and approve validation protocols; support execution, interpret data, and generate final reports
• Develop and maintain Validation Master Plans (VMPs)
• Support process validation, cleaning validation, and aseptic process simulations (media fills)
• Lead validation of critical utilities including Water for Injection (WFI), clean steam, HVAC systems, and compressed gases (CDA, nitrogen)
• Perform environmental qualification and airflow visualization (smoke studies)
• Validate computerized systems in accordance with GAMP 5 and 21 CFR Part 11
• Ensure data integrity compliance in alignment with ALCOA+ principles
• Support automation and control systems validation (PLC, SCADA, etc.)
• Ensure compliance with FDA cGMP (21 CFR Parts 210/211) and EU GMP Annex 1
• Support regulatory inspections, customer audits, and audit responses

Technical Leadership & Continuous Improvement

• Act as a Subject Matter Expert (SME) in validation and sterile manufacturing environments
• Lead change controls, deviations, CAPAs, and risk assessments (e.g., FMEA)
• Drive continuous improvement initiatives to enhance compliance, efficiency, and operational robustness

Qualifications

• Bachelor’s degree in Engineering or related Life Sciences field
• Strong technical writing and documentation skills
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)

Experience

• 3+ years of hands-on validation experience within sterile injectable pharmaceutical or biopharmaceutical manufacturing environments