An exciting opportunity has opened within the Validation team for a
Senior Validation Engineer
. In this role, you'll be responsible for delivering on the qualification and validation program, including the planning and execution of validation and requalification activities on critical facilities and equipment. The position will focus on
cleanroom environmental monitoring qualification
to support changes and expansion of the existing production environment.
There may be a requirement to work on shift to support critical project milestones.
Key Responsibilities:
• Provide technical validation support throughout the full validation lifecycle process
• Develop, review, and approve validation plans, protocols, discrepancies, and summary reports
• Lead strategy development and risk assessments for environmental monitoring qualification
• Plan and execute environmental qualification activities in accordance with EU & FDA regulations
• Support execution of airflow visualization (smoke) studies, filter integrity, velocity, and particle monitoring testing
• Coordinate projects and prioritize workload in line with site priorities
• Participate in multidisciplinary teams, including investigations and change control
• Collate and report validation data and metrics
• Support continuous improvement and compliance initiatives across the validation lifecycle
Basic Qualifications:
• Bachelor's degree in Science or Engineering (Microbiology qualification desirable)
• Minimum of 5 years' experience in a similar validation role within pharma/biotech
• Strong knowledge of cGMP and global regulatory standards
• Excellent communication, organization, and problem-solving skills
Preferred Experience:
• Experience qualifying cleanroom facilities and/or HVAC systems
• Familiarity with Quality and Document Management Systems (e.g., Maximo, Veeva, Kneat)
• Independent, proactive, and team-oriented approach