Validation Engineer

We are seeking a skilled Validation Engineer to join our dynamic team here at CPI. We are looking for one individual to join the team but will accept applications from Engineers at both a junior and a senior level.

The Validation Engineer possesses a diverse range of experience in pharmaceutical validation processes, with a strong foundation in the qualification of equipment and utilities and with a particular interest in automated manufacturing systems and Pharma 4.0. The Validation Engineer will play a critical role in ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements and their contributions directly impact product quality and patient safety.

The Validation Engineer will play a pivotal role in the validation of new manufacturing equipment, starting with the introduction of Oligonucleotide manufacturing capability within the existing facilities and culminating in the opening of a new, purpose-built facility for Oligonucleotide production. They will collaborate closely with cross-functional teams, including Quality Assurance, Operations, and Engineering. Reporting to the Validation Manager, the role demands meticulous attention to detail and a proactive approach to problem-solving. The successful candidate will support the validation lifecycle, from initial risk assessments through to final report generation, adhering to stringent timelines., Key tasks in the Validation Engineer role will include (but are not limited to the below), please download the job description for full details available on the CPI careers page:

• 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.
  
  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


It would be great if you also had:

• 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 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, 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