Validation Specialist

2 weeks ago

Stevenage, Hertfordshire, United Kingdom myGwork Full time

This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Role Summary

Qualification and validation of manufacturing systems capable of producing high quality drug products for use in Autolus clinical trial and later commercial programs. The role is based within the Autolus Manufacturing sites, Stevenage, but may involve travel to other sites in London such as White City. They will perform qualification and validation of appropriate facilities, equipment, utilities, processes and authoring of validation lifecycle documents.

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.
• Write and manage project plans for simple validation projects.
• 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.
• Undertake any other reasonable tasks that are requested to help ensure that appropriate compliance is achieved and maintained within the company’s validated systems.

Demonstrated skills and competencies

E – Essential P – Preferred

Experience
• Directly relevant biotechnology, pharmaceutical or medical device industry experience. (E)
• Prior experience with biopharmaceutical or related industry processes. (E)
• Prior experience in qualification of biopharmaceutical (or related industry) process equipment and processes. (E)
Qualifications
• BS or MS in Engineering or science-based discipline. (P)

Skills/Specialist knowledge
• Good understanding of cell biology and immunology (P)
• Strong verbal and written communication skills (E)
• Flexible, self-motivated and focus on team outcomes (E)
• Understanding of and familiarity with regulatory guidance governing cell-based and biopharmaceutical development (E)
• Excellent team-working and interpersonal skills (E)
• Thorough knowledge of cGMP as applied in biopharmaceutical or related industry (E)
• Thorough knowledge of cGMP pharmaceutical quality systems (change control, deviation and CAPA processes) (E).

#LI-DNI

  • Industrial Validation Specialist

    4 weeks ago

    Stevenage, Hertfordshire, United Kingdom Certain Advantage Full time

    Industrial Validation SpecialistCertain Advantage is seeking an Industrial Validation Specialist to join our team. As an Industrial Validation Specialist, you will be responsible for validating the external supply chain to ensure successful delivery of parts required to support development programmes in preparation for full rate production.Key...

  • Industrial Validation Specialist

    4 weeks ago

    Stevenage, Hertfordshire, United Kingdom Certain Advantage Full time

    Job Title: Industrial Validation SpecialistJob Summary:We are seeking an experienced Industrial Validation Specialist to join our team at Certain Advantage. As an Industrial Validation Specialist, you will be responsible for validating the external supply chain to ensure successful delivery of parts required to support development programmes in preparation...

  • Industrial Validation Specialist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom https:www.energyjobline.comsitemap Full time

    Certain Advantage is seeking a skilled Industrial Validation Specialist to join our team. As an Industrial Validation Specialist, you will be responsible for validating the external supply chain to ensure successful delivery of parts required to support development programmes in preparation for full rate production.Key Responsibilities:Manage a portfolio of...

  • Systems Integration and Validation Specialist

    4 weeks ago

    Stevenage, Hertfordshire, United Kingdom Cirrus Selection Limited Full time

    Job Title: Systems Integration and Validation SpecialistAbout the Role:We are seeking a highly skilled Systems Integration and Validation Specialist to join our team at Cirrus Selection Limited. As a key member of our Integration and Systems Validation team, you will be responsible for planning and executing trials to integrate and test systems and subsystem...

  • Industrial Validation Specialist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom supplychainonline.co - Jobboard Full time

    Industrial Validation Specialist required for a long-term contract assignment based in the UK.Overview of the role:A capable and responsive manufacturing/quality professional is needed to join the Supply Chain in Development team. They will take a leading role interfacing with Procurement and Supply Chain professionals and external supply partners. The...

  • Integration and Validation Lead

    3 weeks ago

    Stevenage, Hertfordshire, United Kingdom Defence Full time

    Job DescriptionTechnical Lead for Integration and ValidationThe opportunity:Defence has a fantastic opportunity for a Lead Integration and Validation Specialist within our Systems Engineering team.The Lead Integration and Validation Specialist role is a diverse position, involving collaboration with Equipment Teams to ensure and execute robust assurance and...

  • Embedded Software Validation Specialist

    1 day ago

    Stevenage, Hertfordshire, United Kingdom Endeavour Recruitment Solutions Full time

    Job Description:We are seeking a highly skilled Embedded Software Validation Specialist to join our Development Facility in Stevenage, Hertfordshire. The successful candidate will be responsible for verifying and validating real-time systems application software for the next generation of Missile Systems.Salary: Up to £90 per hour PAYE or up to £45 per...

  • Electrical Systems Validation Specialist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom https:www.forcesfamiliesjobs.co.uksitemap Full time

    Job Title: Electrical Systems Validation SpecialistJob Summary: We are seeking an experienced Electrical Systems Validation Specialist to join our team. The successful candidate will be responsible for planning and executing trials, ensuring adequate trials data is acquired, and investigating and resolving design issues.Key Responsibilities:Work with the...

  • Electrical Systems Validation Specialist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom The Institution Of Engineering And Technology Full time

    Job Title: Electrical Systems Validation SpecialistJob Summary: We are seeking an experienced Electrical Systems Validation Specialist to join our team. The successful candidate will be responsible for planning and executing trials, liaising with design teams, and conducting post-trials data analysis and reporting.Key Responsibilities:Work with the systems...

  • Integration and Systems Validation Specialist

    4 weeks ago

    Stevenage, Hertfordshire, United Kingdom MBDA Full time

    Job Title: Integration and Systems Validation SpecialistJob Summary:MBDA is seeking a skilled Integration and Systems Validation Specialist to join our team. As a key member of our engineering team, you will be responsible for planning and executing trials, generating trials documentation, and conducting post-trials data analysis and reporting.Key...

  • Electrical Systems Validation Specialist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom MBDA UK Ltd Full time

    Job Title: Electrical Systems Validation SpecialistJob Summary: We are seeking an experienced Electrical Systems Validation Specialist to join our team at MBDA UK Ltd. The successful candidate will be responsible for planning and executing trials, ensuring adequate trials data is acquired, and investigating and resolving design issues.Key...

  • Industrial Validation Specialist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom supplychainonline.co - Jobboard Full time

    Industrial Validation Engineer Job Description:An opportunity has arisen in an expanding team responsible for validating the external supply chain to ensure successful delivery of parts required to support development programmes in preparation for full-rate production.This role requires an individual with experience in manufacturing engineering, quality, and...

  • Industrial Validation Specialist

    4 weeks ago

    Stevenage, Hertfordshire, United Kingdom Certain Advantage Full time

    Industrial Validation Engineer Job DescriptionCertain Advantage is seeking a skilled Industrial Validation Engineer to join our team on an initial 9-month contract. The role can be based at either our Bolton or Stevenage site, with the option to work from home 1-2 days per week.This opportunity is ideal for a candidate with a strong background in...

  • Industrial Validation Specialist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom https:www.energyjobline.comsitemap Full time

    Industrial Validation Engineer Job Description:An opportunity has arisen in an expanding team responsible for validating the external supply chain to ensure successful delivery of parts required to support development programmes in preparation for full-rate production.This role requires an individual with experience in manufacturing engineering, quality, and...

  • Senior Systems Integration and Validation Specialist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom fish4.co - Jobboard Full time

    Electronic Engineering has an exciting opportunity for a Senior Systems Integration and Validation Specialist to join our growing Integration and Validation (Systems Engineering) team.The successful candidate will be responsible for working with Equipment Teams to ensure and execute robust assurance and compliance strategies, as well as taking on some...

  • Verification and Validation Specialist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom Endeavour Recruitment Solutions Full time

    Verification and Validation EngineerWe are seeking a highly skilled Verification and Validation Engineer to join our team in Stevenage, Hertfordshire. As a key member of our Development Facility, you will be responsible for verifying and validating real-time systems application software for the next generation of Missile Systems.Key...

  • Electrical Systems Validation Specialist

    1 day ago

    Stevenage, Hertfordshire, United Kingdom MBDA UK Ltd Full time

    Job DescriptionWe are seeking an experienced Electrical Systems Validation Specialist to join our team at MBDA UK Ltd. As a key member of our engineering team, you will be responsible for ensuring the electrical systems of our defence products meet the required standards.Key Responsibilities:Work with the systems engineering team and design teams to plan and...

  • Senior Integration and Validation Specialist

    4 weeks ago

    Stevenage, Hertfordshire, United Kingdom Certain Advantage Full time

    Job DescriptionCertain Advantage is seeking a highly skilled Integration and Validation Lead to join our team on a 12-month contract. This hybrid role will involve working from home and onsite, providing a great work-life balance.The successful candidate will have experience in Systems Engineering, Verification and Validation (V&V), Integration and Systems,...

  • Integration and Systems Validation Specialist

    4 weeks ago

    Stevenage, Hertfordshire, United Kingdom Cirrus Selection Limited Full time

    Job Description for Integration & Systems Validation EngineerCirrus Selection Limited is seeking a skilled Integration & Systems Validation Engineer to join our team in the Air Defence domain. As a member of our Integration and Systems Validation team, you will be responsible for the completion of a range of activities required to integrate and test systems...

  • Senior Integration and Systems Validation Specialist

    1 month ago

    Stevenage, Hertfordshire, United Kingdom fish4.co - Jobboard Full time

    Job Title: Senior Integration and Systems Validation SpecialistContract: PermanentSalary: £45,000Location: StevenageKey Responsibilities:Collaborate with systems engineering and design teams to plan and integrate system and subsystem trials.Investigate and resolve design issues, ensuring sufficient trial data acquisition.Prepare and present trial readiness...