Principal BioPharma Manufacturing Validation Engineer

About Astellas

Astellis is a global life sciences company dedicated to transforming innovative science into value for patients. They provide transformative therapies in areas such as oncology, ophthalmology, urology, immunology, and women's health. Through their research and development efforts, they are pioneering new healthcare solutions for diseases with significant unmet medical needs. For more information, visit Astellas.com.

Purpose & Scope

The Principal Validation Engineer is a senior technical leader and Validation subject matter expert responsible for defining and executing an integrated, risk-based validation strategy to ensure facilities, utilities, equipment, computerized systems, cleaning, and manufacturing processes are qualified and maintained in a state of control to support Process Performance Qualification (PPQ), regulatory filing, licensure, and sustained commercial supply. This role provides strategic and hands-on leadership for PPQ planning and readiness, authorship and review of validation lifecycle deliverables, regulatory inspection readiness, and mentoring of junior team members across the organization.

Role And Responsibilities

• Lead the site validation strategy and lifecycle execution for facilities, utilities, equipment, computerized systems, cleaning, and manufacturing processes to support PPQ, licensure, and sustained commercial operations.
• Serve as the site Validation SME for PPQ planning and readiness, including validation strategy, risk assessments, protocols, summary reports, discrepancy resolution, and cross-functional execution support.
• 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 and 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 cross-functionally, providing guidance in support of the continuous improvement, monitoring and sustaining validation practices and records.
• Ensure 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 through effective processes and 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.
• Provide oversight for regulatory submission documentation to ensure timely licensure of new cell or gene therapy products in multiple regions and 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.
• Independently lead capital validation projects and other complex, high-risk validation deliverables that directly impact PPQ readiness, regulatory filing and licensure milestones, inspection readiness, and sustained commercial operations.
• Manage schedule, budget, and technical scope for assigned validation activities; provide regular updates to key stakeholders; influence cross-functional decisions that affect compliance and business continuity; and provide technical oversight for contract resources and external partners, including onboarding and offboarding decisions as needed.
• Play a key role in strengthening the site validation program by providing SME input to standards, procedures, and practices, and by managing deliverables required to establish and maintain revalidation plans and the validated state of the site.

Required Qualifications

• BS in Engineering or related discipline with 10+ years of direct validation engineering experience, or MS in Engineering or related discipline with 8+ years of direct validation engineering experience, in a GMP biopharmaceutical, biologics, cell therapy, or gene therapy manufacturing environment.
• Demonstrated experience leading validation strategy and execution in support of Process Performance Qualification (PPQ), including readiness planning, risk assessments, protocol development, execution support, discrepancy resolution, and summary reporting.
• Strong knowledge of risk-based commissioning, qualification, and validation for facilities, utilities, equipment, computerized systems, cleaning, and manufacturing processes in a commercial readiness environment.
• Demonstrated experience preparing, reviewing, and/or providing strategic oversight of validation documentation that supports regulatory filings, licensure, health authority inspections, and ongoing inspection readiness.
• Strong understanding of global GMP and regulatory expectations related to validation lifecycle management, data integrity, quality risk management, and maintenance of validated state.
• Demonstrated leadership, critical thinking, and ability to influence cross-functional teams and senior stakeholders to achieve complex, high-impact milestones.
• Proven ability to mentor and develop junior team members, provide technical guidance, and promote consistent, compliant validation practices across the organization.
• Strong and effective problem-solving skills, with the ability to make sound, science-based decisions under pressure while maintaining quality, compliance, and business continuity.

Preferred Qualifications

• 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.