Quality Assurance (QA) Validation Engineer at Astellas Gene Therapies (Orlando, FL)

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Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients’ lives? Astellas Gene Therapies is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you’d like to be a part of this important mission, please apply to join our team.

About Astellas Gene Therapies

Astellas Gene Therapies is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.audentestx.com.

Our Values:

  • Be BOLD (Find a Way)
  • Care Deeply – for our patients, each other and our work
  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Reporting to the Manager, Quality Assurance (QA) the QA Validation Engineer will be primarily responsible for the implementation, execution, and assessment of quality systems, procedures, and records to support compliant GMP operations. Responsibilities include ensuring adherence to agency regulations (GxP) and guidance, industry best practices, local regulations, and internal policies and procedures. This position works closely with Validation, Engineering, Manufacturing, Facilities, Document/Data Management, and other GxP supporting functions to ensure compliance. This is accomplished by direct collaboration and oversight of Validation, Facilities/Engineering, Manufacturing Operations, and the review/audit of data and reports as specified by Standard Operating Procedures. This position will be based in our Sanford, NC facility.

Primary Responsibilities

  • Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.
  • Partner with the Validation team to define validation strategies as it relates to PPQ and prerequisites and support validation project implementation to ensure new production facility is brought online within timelines and with a high degree of quality.
  • Perform review and approval of commissioning and qualification documents for equipment, systems, and processes following established standards and templates, including but not limited to the following:
    • Validation plans including project plans and validation status lists.
    • Specification documentation: e.g., URS, DS, FRS.
    • Risk Assessments and Impact Assessments.
    • Qualification / validation protocols, e.g., IQ/OQ/PQ and Summary Reports.
    • Protocol Discrepancies and associated corrective actions
    • Engineering Change Record
    • Standard Operating Procedures related to validation execution.
  • Ensure the quality of validation documentation that is generated to support a cGMP regulated biologics manufacturing environment, with a focus on novel challenges of cell based and gene therapies, e.g. Right the First Time Focus.
  • Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOP’s, specifications, protocols, and reports
  • Author, review, and approve Quality System records including Deviation, CAPA, and Change records including associated causal and impact assessments
  • Facilitate risk assessment, cross functional team discussions in support of major/critical deviation investigations and change controls
  • Work closely with validation, equipment owners, and other key stakeholders in support of the development of and subsequent qualifications and validations of facility and technical systems.
  • Define, track, and report quality metrics
  • Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed

About you

Must Have/Required

  • Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.
  • Partner with the Validation team to define validation strategies as it relates to PPQ and prerequisites and support validation project implementation to ensure new production facility is brought online within timelines and with a high degree of quality.
  • Perform review and approval of commissioning and qualification documents for equipment, systems, and processes following established standards and templates, including but not limited to the following:
    • Validation plans including project plans and validation status lists.
    • Specification documentation: e.g., URS, DS, FRS.
    • Risk Assessments and Impact Assessments.
    • Qualification / validation protocols, e.g., IQ/OQ/PQ and Summary Reports.
    • Protocol Discrepancies and associated corrective actions
    • Engineering Change Record
    • Standard Operating Procedures related to validation execution.
  • Ensure the quality of validation documentation that is generated to support a cGMP regulated biologics manufacturing environment, with a focus on novel challenges of cell based and gene therapies, e.g. Right the First Time Focus.
  • Author, review, and approve controlled documents for the Quality organization and other GMP functional areas including SOP’s, specifications, protocols, and reports
  • Author, review, and approve Quality System records including Deviation, CAPA, and Change records including associated causal and impact assessments
  • Facilitate risk assessment, cross functional team discussions in support of major/critical deviation investigations and change controls
  • Work closely with validation, equipment owners, and other key stakeholders in support of the development of and subsequent qualifications and validations of facility and technical systems.
  • Define, track, and report quality metrics
  • Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed
  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Experience reviewing and approving commissioning and qualification documentation
  • Experience with rare diseases, neuromuscular diseases and/or gene therapy products
  • Experience in a facility startup and licensure environment
  • Experience in a commercial-ready gene therapy facility
  • Experience in a small company and high growth, fast-paced environment

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

More Information on Astellas Gene Therapies
Astellas Gene Therapies operates in the Biotech industry. The company is located in San Francisco, CA. Astellas Gene Therapies was founded in 2012. It has 395 total employees. To see all jobs at Astellas Gene Therapies, click here.
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