Validation Specialist

3 weeks ago

Glasgow, Glasgow City, United Kingdom CPI Full time
About the Role

We are seeking a skilled Validation Specialist to join our dynamic team at CPI. As a key member of our team, you will play a critical role in ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

Key Responsibilities
  • Develop, review, and execute validation protocols and reports for pharmaceutical processes, equipment, facilities, and systems, including automated systems.
  • Collaborate with cross-functional teams to ensure accurate and thorough documentation in compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
  • Conduct validation studies, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), also some process validation, cleaning validation, and computer system validation.
  • Maintain accurate and organized validation documentation.
  • Document protocols, reports, deviations, and change controls.
  • Collaborate with Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs teams.
  • Identify opportunities for process optimization and efficiency enhancements within the validation framework.
  • Drive continuous improvement initiatives.
Requirements
  • Educated to HNC or Foundation Degree level (or equivalent) in a Validation discipline plus relevant industrial experience OR Educated to Degree level (or equivalent) in Engineering, Chemistry, Life Sciences discipline plus significant industrial experience.
  • Strong understanding of validation principles, including the application of risk assessment in the development of validation processes, protocol development, execution, and reporting.
  • Proficiency in one or more validation areas such as equipment qualification, process validation, cleaning validation, or computer system validation.
  • Familiarity with regulatory guidelines (e.g., FDA 21 CFR Part 11, EU Annex 11, ICH guidelines) and industry standards (e.g., GAMP)
  • Excellent communication skills with the ability to effectively collaborate with cross-functional teams and stakeholders.
  • Detail-oriented with a focus on accuracy and compliance.
  • Proven ability to manage multiple projects simultaneously and meet tight deadlines
Desirable Qualifications
  • Chartered or working toward Chartered status with a relevant professional institution.
  • Experience with statistical analysis tools for validation data analysis.
  • Knowledge of emerging trends and technologies in pharmaceutical validation, such as PAT (Process Analytical Technology), QbD (Quality by Design), and validation software/tools (e.g., Kneat, Valgenesis, MasterControl).
About CPI

CPI offers a wide range of benefits to our employees, including:

  • 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

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