Principal Biopharma Validation Lead – PPQ & Compliance

astellas; Massachusetts; On-site; USD 119,000 - 170,000; Full time

Job summary

Astellas in Massachusetts seeks a Principal BioPharma Manufacturing Validation Engineer to lead site validation strategy for facilities, utilities, equipment, computerized systems, and processes, ensuring PPQ readiness and regulatory licensure.

This senior role provides strategic leadership, mentors junior staff, manages budgets and schedules, and drives risk-based validation in support of ongoing commercial supply and inspection readiness.

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.

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.
• 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 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.

Skills

Validation engineering

PPQ planning

Risk-based validation

GMP compliance

Regulatory filings

Leadership

Mentoring

Change control

Education

BS in Engineering or related discipline

MS in Engineering or related discipline

Job description

Astellas in Massachusetts seeks a Principal BioPharma Manufacturing Validation Engineer to lead site validation strategy for facilities, utilities, equipment, computerized systems, and processes, ensuring PPQ readiness and regulatory licensure.

This senior role provides strategic leadership, mentors junior staff, manages budgets and schedules, and drives risk-based validation in support of ongoing commercial supply and inspection readiness.