Validation Specialist
4 weeks ago
Job Summary:
Autolus Ltd is seeking a highly skilled Validation Specialist to join our team. The successful candidate will be responsible for the qualification and validation of manufacturing systems, ensuring compliance with regulatory requirements and company procedures.
Key Responsibilities:
- Perform qualification and validation of manufacturing equipment, analytical test equipment, facilities, services, computerised systems and processes in line with company procedures, EudraLex Vol 4 Annex 11 and 15, relevant FDA regulations and national and international standards.
- Write qualification and validation lifecycle documents including impact risk assessments, electronic record, electronic signature and data integrity assessments, GAMP assessments, user requirement specifications, design qualification, installation qualification, operational qualification, performance qualification.
- Work effectively with cross-functional team members to deliver tasks to schedule.
- Perform validation testing with third-party vendors and suppliers to the required company standards.
- Support maintenance of the validation master plan, requalification and periodic reviews of validated facilities, utilities, equipment and processes.
- Participate in and support internal and regulatory authority Quality inspections.
Requirements:
- Directly relevant biotechnology, pharmaceutical or medical device industry experience.
- Prior experience with biopharmaceutical or related industry processes.
- Prior experience in qualification of biopharmaceutical (or related industry) process equipment and processes.
Skills and Qualifications:
- BS or MS in Engineering or science-based discipline.
- Good understanding of cell biology and immunology.
- Strong verbal and written communication skills.
- Flexible, self-motivated and focus on team outcomes.
- Understanding of and familiarity with regulatory guidance governing cell-based and biopharmaceutical development.
- Excellent team-working and interpersonal skills.
- Thorough knowledge of cGMP as applied in biopharmaceutical or related industry.
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