Hobson Prior is currently seeking a Senior Validation Engineer for a permanent role. The key area of focus for this role is Antibody Drug Conjugates (ADC). The Senior Validation Engineer will be responsible for generating and maintaining the ADC Validation Master Plan & Revalidation Plan, as well as generating essential validation documents to support facility start-up and tech transfer of ADC products.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• For this role, you will develop and upkeep the ADC Validation Master Plan & Revalidation Plan.
• Produce critical validation documents like protocols, reports, and test plans to facilitate facility initiation and tech transfer of ADC products.
• Revise or create validation policies and procedures to integrate ADC validation methods into the company's validation framework.
• Execute the ADC containment verification program, including training personnel, revalidation, and certification processes.
• Conduct designated validation impact assessments.

Requirements

• Proficient in aiding regulatory agency inspections as an ADC validation subject matter expert and addressing inspection & customer audit findings.
• Specialized in ADC equipment, facility, and cleaning procedures.
• Proficient in Isolator qualification and evaluating containment performance.
• Leadership qualities - Agility, adaptability, and accountability should be exhibited. Proficiency in working independently and making well-founded decisions with minimal oversight should also be demonstrated.

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.

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