Senior Validation Engineer

Job summary

An experienced Senior Validation Engineer is needed to lead validation efforts for Cleanrooms, Classified Environments, and Clean Utilities, ensuring compliance with global regulatory standards. This role requires a strong technical background and the ability to provide strategic direction for validation activities in controlled GMP environments.

Qualifications

• Bachelor's, Master's, or equivalent degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field.
• Minimum of 8 years of relevant experience in HVAC/Cleanroom and Clean Utility GMP validation within the pharmaceutical, biotechnology, or life sciences sectors.
• Extensive experience in qualifying and maintaining HVAC systems, Cleanrooms, Clean Air Devices, and Clean Utilities.
• Strong background in VPP development, IQ/OQ/PQ, Requalification programs, Quality Risk Management, Change Control, Deviations, Investigations, CAPAs, and CQV.
• In-depth knowledge of EU GMP Annex 1, EU GMP Annex 15, ICH Q8/Q9/Q10, ISPE Guidance, ISO 14644 standards, ASTM E2500, GAMP Principles, and FDA regulations.
• Proven experience in supporting regulatory inspections and addressing observations from health authorities.

Responsibilities

• Act as Validation SME for Clean Utilities and Cleanrooms, including HVAC and Environmental Control Systems.
• Own the validation program for Cleanrooms and Clean Air Devices.
• Lead inspection readiness activities and manage remediation of audit findings.
• Make decisions on validation strategies and risk-based approaches.
• Oversee validation activities including VPP, Commissioning & Qualification Strategies, and Quality Risk Assessments.
• Conduct technical validation for cleanroom qualification, including airflow visualization and environmental qualification.

Skills

• Strong decision-making and stakeholder influence capabilities.
• Solution-oriented with a focus on balancing compliance and business needs.
• Self-motivated with the ability to work autonomously.
• Excellent organizational skills with the ability to manage multiple priorities.
• Strong interpersonal skills and respected for technical credibility.

Education

• Relevant degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related discipline.

Tools

• Familiarity with validation tools and methodologies relevant to GMP environments.