Validation Specialist

at  Ipsen Biopharm Ltd

Ipsen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care.
The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make a difference. We attract and develop bold, agile and entrepreneurial individuals who take full ownership of their decisions, leaders drawn by a purpose to make a direct impact through their work in people’s lives, all of which is underpinned by our Ipsen Way of Being.
In the role of Validation Specialist, you will be focussed on supporting the wider engineering team in defining, executing and reporting on validation activities associated with facilities, utilities and process equipment, performing IQ, OQ and PQ studies to ensure optimal performance and output.
Furthermore, we are currently expanding our footprint with the addition of a New Drug Product facility which represents a signifiant investment in the Wrexham site and subsequently exciting project work in addition to the day-to-day role.

KEY REQUIREMENTS

• Prior experience in pharmaceutical/biotech/cleanroom/GMP environment
• Good understanding of the qualification / validation lifecycles
• Knowledge of current regulatory requirements and industry guidance /standards associated with validation activities
• Experienced in the execution of qualification and validation activities - IQ, OQ, PQ etc.
• Appreciation for technical, compliance and practical understanding of specific validation activities as defined by the Validation Manager.
• Basic understanding of quality risk assessment principles and tools and their application throughout a risk-based qualification lifecycle.
• Competent in the generation and review of technical documentation.

• Define, execute and report qualification, re-qualification and validation studies in order to establish and maintain the qualified/validated status of range of status of facilities, utilities, equipment and processes in accordance with internal procedures, regulatory requirements and industry guidance/standards.
• Subject Matter Experts for the specific validation activities as defined by the Qualification and Calibration Manager
• Investigation and compliant resolution of non-conformances encountered during requalification, revalidation and periodic review activities (with support from senior validation team members)
• Contribute a risk-based validation approach through participation in risk assessment utilizing QRM principles and tools such FMEA, HAZOP etc., to ensure risks are appropriately identified and documented
• Identification and implementation of Continuous Improvement initiatives to ensure lean way of working