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Astellas Pharma Senior Validation Engineer in Sanford, North Carolina

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 Right. 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 (AGT), an Astellas Company, 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 their 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.astellasgenetherapies

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

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

The Senior Validation Engineer will be responsible for implementation and execution of the validation and revalidation activities for facilities, utilities, equipment, analytical equipment, as well as helping to establish cleaning and process validation programs. The position will be a leader and Subject Matter Expert (SME) in multiple validation disciplines and responsible for determining and leading validation strategy, managing and executing validation projects and drafting regulatory submissions to ensure licensure for a new commercial gene therapy facility. The role will involve both building the validation program at the new production facility as well as performing protocol executions and managing contract resources to establish, implement, and oversee qualification and validation procedures and practices in accordance with FDA, EMA, ICH, AGT policies and procedures and industry best practices.

Responsibilities

  • Lead validation project teams, managing contract support, drafting, and leading validation projects while ensuring compliance and implementation of data integrity

  • Manage contract C&Q support staff to qualify facility, equipment, utilities, and QC equipment for GMP readiness and lead and train junior AGT employees on validation methods and industry best practices.

  • Review and approve validation documentation for facilities, equipment, utilities, and QC equipment for GMP readiness including specification documentation e.g.: URS/FRS/DS/IQ/OQ/DQ/TM/PQ

  • Partner with AGT Validation group in SSF, California to implement and maintain an aligned validation program for the new production facility

  • Define validation strategies as it relates to PPQ and prerequisites and drive validation project implementation to ensure GMP readiness and draft validation program documents in alignment with defined AGT validation program.

  • Draft regulatory submission documents to ensure timely licensure of new gene therapy products in multiple regions and review and implement validation procedures that provide instruction for the execution and maintenance of the validation program including CSV, QC method, facility, utility, equipment, and process validation.

  • 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

  • Design specific validation protocols, leads the execution of the validation studies including resolving technical issues, evaluating results, and generating reports and lead validation process and present programs to regulatory inspectors and internal auditors during inspections and internal/partner audits

  • Work closely with stakeholders including Quality Operations, equipment providers and capital project teams in support of the development of and subsequent qualifications and validations of facility and technical systems.

  • Independently manage scope, schedule and resources to ensure the timely completion of multiple validation projects. Assess and resolve validation impact of change controls, deviations and discrepancies encountered during validation execution through science-based quality risk assessments. Will Compile, analyze and manage validation data and records and ensure approval and archival within the AGT quality system.

Quantitative Dimensions

The Senior Validation Engineer will be responsible for the successful implementation and execution of the validation processes, the leadership of the validation teams, and partnership with vendors and contractors to ensure quality and all regulations are followed. This role will ensure all validation data and records receive approval and archived accordingly.

Organizational Context

The Senior Validation Engineer will typically report to the Senior Manager, Validation. This role is expected to model our core values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

Required Qualifications

  • Industry experience with typically 10+ years relevant experience, or BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study with typically 6+ years relevant experience or Master’s degree with a typically 4+ years relevant experience.

  • Strong knowledge of risk-based approach to commissioning, qualification, and validation activities in a biotech manufacturing environment and demonstrated leadership, critical thinking skills, and ability to influence across the organization to achieve milestones.

  • Direct experience in regulatory compliance with respect to validation along with strong problem-solving, decision-making skills, interpersonal skills, and ability to work in a team and strong understanding of FDA, EMA, local regulations and guidelines, Good Engineering Practices, ICH guidelines, and industry best practices.

  • Validation experience using risk-based approaches, e.g., failure mode and effects analysis, hazard analysis and critical control points and experience with investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions.

  • Excellent technical writing, verbal communication, and time management skills and knowledge of quality systems with experience in validation quality system implementation.

  • Established record of building and maintaining validation programs and demonstrated ability to work within a matrixed team located in different plants to implement existing validation program, tailored to a commercial gene therapy production plant.

  • Will support and demonstrate quality standards to ensure data of the highest quality and works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned.

Preferred Qualifications

  • Experience in a facility startup and licensure environment

  • Experience in managing revalidation programs

  • Experience working with Quality systems in a commercial-ready gene therapy facility

  • Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines

  • Ability to deal with ambiguity, creative and pragmatic approach to problem solving

  • Exposure of regulatory authority inspections and inspection readiness

Working Conditions

  • This role frequently requires periods of sitting, standing and physical activity in a regulated manufacturing environment that may on occasion require bending, stooping, overhead reaching, and lifting objects or navigating equipment 5- 20lbs.

  • This is an on-site role working in a cGMP Regulated Manufacturing facility.

  • On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-10%).

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation, Sick time, national holidays, two Heritage Days, and Summer and Winter Breaks

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

Category Gene Therapy Research & Technical Operations

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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