Validation Specialist

Hobson Prior is currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This pioneering company is looking for a Validation Specialist to work within the Facility Engineering department to support GMP manufacturing activities and ensure compliance with regards to the Validation program.

Job Responsibilities:

• Accountable to support the qualification activities of various equipment and systems for the manufacturing, quality control and engineering departments.
• Overseeing the execution of validation protocols.
• Completion of validation summary reports.
• Reviewing and approving external validation documents.
• Responsible for writing validation documents IQ/OQ/PQ.
• Working closely with the Engineering, Production, QC and QA departments to ensure a timely delivery of the qualification reports and the effective closure of quality records, as well as the completion of CAPAs and non-conformances generated during validation/qualification activities.
• Assisting system owners with system/equipment URS and DQ documents and using a risk-based approach to determine the appropriate validation requirements.
• Managing validation reviews, re-qualifications and revalidations to ensure maintenance of the 'validated state' and ongoing GMP compliance.
• Assist with CSV and GAMP compliance where required.

Key Skills:

• Excellent communication skills.
• Good organisational and planning skills.
• Good written communication and report writing skills.
• Problem solving.

Requirements:

• Qualified to Degree/H.N.C. in an engineering/validation/QA discipline.
• In Gene Therapy/Pharmaceutical background would be desirable.
• Additional languages would be an advantage but is not essential.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.