Principal BioPharma Manufacturing Validation Engineer

Astellas Pharma; Westborough (MA); On-site; USD 119,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Generous Paid Time Off

401(k) match

Annual Corporate Bonus

Job summary

Astellas Pharma, located in Westborough, Massachusetts, is seeking a Principal Validation Engineer to lead site validation strategies and lifecycle execution. The ideal candidate has at least 10 years of validation engineering experience in a GMP environment and a proven track record of supporting regulatory filings.

This role involves collaboration with cross-functional teams, management of validation service providers, and oversight of regulatory documentation. The position offers a comprehensive benefits package including health insurance and generous paid time off.

Qualifications

• 10+ years of direct validation engineering experience in GMP biopharmaceutical environments.
• Experience leading validation strategy and execution.
• Strong knowledge of risk-based commissioning and qualification.

Responsibilities

• Lead site validation strategy and lifecycle execution.
• Serve as the site Validation SME for PPQ planning.
• Manage contracted validation service providers.

Skills

Validation engineering experience

Risk assessment

Leadership

Problem-solving

Quality risk management

Education

BS in Engineering or related discipline

MS in Engineering or related discipline

Job description

About Astellas

Astellas is a global life sciences company committed to turning innovative science into value for patients. We provide transformative therapies in oncology, ophthalmology, urology, immunology, and women’s health. Through our research and development programs, we pioneer new healthcare solutions for diseases with high unmet medical need.

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.
• 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.

Principal Validation Engineer Responsibilities

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%).

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

EEO Statement

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.