CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.
Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.
From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.
At CPI, quality is one of our founding principles. Through robust quality management and a strong compliance culture, we support the delivery of innovative, safe, and effective manufacturing technologies across the life sciences sector. As we continue to grow and develop the Medicines Manufacturing Innovation Centre in Glasgow, we're looking for a skilled Quality Validation Specialist to join our team.
Key tasks in the role will include (but are not limited to the below):
Deliver CPI’s validation philosophy and support the development of validation strategies across multiple projects.
Develop and manage validation policies, SOPs, protocols, and documentation.
Review and approve validation and qualification activities for facilities, utilities, equipment, and operations.
Work with technical project teams to embed GMP compliance from specification through to operations.
Liaise with external stakeholders, including MHRA, to ensure regulatory alignment.
Support the Pharmaceutical Quality System: deviations, CAPAs, change control, investigations, and continuous improvement.
Author, review, and approve GMP documentation.
Support internal and external audits.
Coach and mentor colleagues to develop capability across the business.
Maintain awareness of evolving GMP, validation, and regulatory requirements.
Essential
HNC/Foundation Degree (plus significant experience) or Degree in a scientific/engineering discipline.
Significant experience in GMP environments, including validation programmes and quality systems.
Strong working knowledge of EU GMP Annex 11 and 15, GAMP, and Data Integrity principles.
Historic knowledge of reviewing and approved critical validation documentation, including but not limited to URS, VMP, and Validation Protocols.
Demonstrated ability to analyse data, apply risk management, and work across multidisciplinary teams.
Proven organisational skills and a thorough, detail-oriented approach.
It would be great if you also had
Membership of a relevant professional body.
Knowledge of ISO 9001 and Annex 1.
Experience with electronic QMS and document management systems.
Experience of Agile Validation Methodology
Experience right-sizing a validation system based on development stage of product.
At CPI, we offer a wide range of benefits to our employees, this includes:
Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
Generous pension scheme
Life assurance and accident insurance schemes
Flexible working
Learning and Development Opportunities
Free parking
Find out more about our culture and benefits.