Senior Validation Engineer

  • Astellas
  • Sanford, NC, USA
  • Aug 15, 2023

Job Description

About Astellas Gene Therapies Astellas Gene Therapies is an Astellas Center of Excellence 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: 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 Our Values: * Be BOLD (Find a Way) * Care Deeply -- for our patients, each other, and our work * #GSDR (Get Stuff Done Right) 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 We are seeking highly motivated Senior and Principal Validation Engineers, reporting to the Associated Director, Validation (Enterprise Engineering & Facilities Team). As part of the Astellas Gene Therapies (AGT) Enterprise Engineering & Facilities team candidates will be responsible for implementing and overseeing validation programs, policies and procedures related to facilities, utilities, equipment, analytical equipment, cleaning validation and process performance qualification for AGT production facilities in the US, both South San Francisco, CA and Sanford, NC. Validation Engineers will be leaders and SMEs who will be accountable for capital project oversight for validation determining and leading validation strategy, managing validation project teams, implementing data integrity into validation practices, and providing guidance for regulatory submissions documentation to ensure licensure of products. The role will be intimately involved in facility start up activities in Sanford, NC and continuous improvement of program structure and procedures for both facilities. The candidate will establish, implement, and oversee qualification and validation procedures and practices in accordance with FDA, EMA, ICH, Japan guidance's, Astellas policies and procedures and industry best practices. Primary Responsibilities * Own validation processes, presenting programs to regulatory inspectors and internal auditors during inspections and internal/partner audits. * Assist in creation of validation program structure to include strategies, policies, procedures, and master plans. * Lead recurring validation forums and/or governance teams. * Manage overarching validation activities and participate in resource planning for capital projects. * Provide guidance for commissioning and qualification of facilities/utilities, equipment, automated systems, process, and QC system validation, excluding method validation. * Review and approve validation documentation associated with capital projects for facilities, equipment, utilities, and QC equipment for GMP readiness. * Assist with resolving technical issues, evaluating results, and generating reporting documentation. * Manage contracted validation service providers to ensure company requirements are fulfilled through effective performance monitoring and established business agreements. * Collaborate with MSAT team validation engineers, providing guidance in support of the continuous improvement, monitoring and sustaining validation practices and records. * Ensures impact to validation status for new systems and changes to existing systems are performed through science-based quality risk assessments. * Collaborate with Quality Assurance to ensure all qualification data and records are compiled, analyzed, and managed thru effective processes. * Collaborate with site-based validation team members to provide guidance, assist to resolve issues/conflicts, and provide mentoring. * Ensure BOH data integrity requirements are incorporated in facilities/utilities, equipment, automated systems, process, and QC system validation activities. * Participate on AGT Data Integrity Integration Team and global data integrity forums for Astellas. * Provide oversight for regulatory submission documentation to ensure timely licensure of new gene therapy products in multiple regions. * Work closely with internal stakeholders, equipment providers, and capital project teams in support of the development of and subsequent qualifications and validations of facility and technical systems. About you Must Have/Required * Principal Validation Engineer Experience: 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. * Senior Validation Engineer Experience: Industry experience with typically 8+ years relevant experience, or BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study with typically 4+ years relevant experience or Master's degree with a typically 2+ years relevant experience. * Strong knowledge of risk-based approach to commissioning, qualification, and validation activities in a biotech manufacturing environment. * Demonstrated leadership, critical thinking skills, and ability to influence across the organization to achieve milestones. * Direct experience in regulatory compliance with respect to validation. * Strong problem-solving, decision-making skills, interpersonal skills, and ability to work in a team. * Strong understanding of FDA, EMA, Japan, 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, etc. * 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. * Knowledge of Quality systems. * Established record of building and maintaining validation programs. * Ability to work within a matrixed team located in different plants to implement validation programs, tailored to a commercial gene therapy production plant. * Some travel (up to 10%) will likely be required. * Models our Core Values: Be Bold, Care Deeply, #GetStuffDoneRight -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted May Have/Preferred * Experience in a facility startup and licensure environment. * 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, maintain accountability 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. Benefits: * Medical, Dental and Vision Insurance * Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down * 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 Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled