Senior Validation Engineer

Job summary

An experienced Senior Validation Engineer is needed to lead validation activities for Cleanrooms and Classified Environments, including HVAC systems and Clean Utilities. This role requires strong technical expertise and regulatory knowledge to ensure compliance in GMP environments while supporting ongoing operations and expansion projects.

Qualifications

• Bachelor's, Master's, or equivalent degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field.
• 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, and Commissioning, Qualification & Validation (CQV).
• In-depth knowledge of EU GMP Annex 1, EU GMP Annex 15, ICH Q8/Q9/Q10, ISPE Guidance, ISO 14644 standards, and FDA regulations.
• Proven experience in supporting regulatory inspections and addressing observations from health authorities.

Responsibilities

• Act as Validation Subject Matter Expert for Clean Utilities and Cleanrooms, including HVAC 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 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 influencing abilities.
• Solution-oriented with a focus on balancing compliance and business needs.
• Self-driven with the ability to manage multiple critical activities under tight deadlines.
• Excellent communication skills across all organizational levels.

Education

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

Tools

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