Principal BioPharma Manufacturing Validation Engineer
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
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.
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.
The Principal Validation Engineer independently leads 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. This role is responsible for managing schedule, budget, and technical scope for assigned validation activities; providing regular updates to key stakeholders; influencing cross-functional decisions that affect compliance and business continuity; and providing technical oversight for contract resources and external partners, including onboarding and offboarding decisions as needed. In addition, the Principal Validation Engineer plays 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.
Location and Working Environment
This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs
This is an on-site role working in a cGMP regulated manufacturing facility
On occasion, this role may travel to other Astellas manufacturing facilities (0-10%)
What awaits you at Astellas?
Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
Values: Innovation, Integrity and Impact sit at the heart of what we do.
Behaviors: We come together as 'One Astellas' , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.
Salary Range
$119,000 - $170,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
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
Company fleet vehicle for eligible positions
Referral bonus program
LI-TR1
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
