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 Validation Engineer II will be responsible for supporting the implementation and execution of qualification, validation, periodic review and revalidation activities for facilities, utilities, manufacturing and analytical equipment, and for assisting in the establishment and maintenance of cleaning and process validation programs. This role functions primarily as an experienced individual contributor, executing validation protocols, authoring validation documentation, and analyzing data in accordance with established site procedures and regulatory expectations. The Validation Engineer II will support validation strategies defined by senior validation leadership, independently lead validation activities for simple or well-defined systems while participating as a core team member on more complex projects. The position may provide technical guidance and day-to-day coordination for contract resources and junior colleagues assisting with validation activities. The role will also support regulatory submissions, inspections, and audits by preparing validation documentation and contributing to regulatory responses under senior oversight, ensuring compliance with FDA, EMA, ICH, company policies, and industry best practices. The role will also support validation-related change control, deviations/investigations, and computerized systems compliance (e.g., data integrity and 21 CFR Part 11/EU Annex 11) as applicable.
Role and Responsibilities
Support and apply validation strategies for facilities, utilities, equipment, analytical systems, cleaning, and process validation.
Serve as a technical contributor and subject-matter resource for assigned systems, including coordination of contractor support.
Author, execute, and approve validation lifecycle documentation for assigned systems in compliance with GMP and data integrity requirements.
Support regulatory submissions, inspections, and audits through preparation of validation documentation.
Independently manage validation activities for simple or well-defined systems, escalating complex issues as needed.
Partner cross-functionally to support GMP readiness and compliant operations.
Support validation impact assessments for GMP change controls, including definition of required testing, documentation updates, and closure deliverables.
Assist with validation-related deviations and investigations by documenting events, assessing product/system impact, and supporting CAPA development under senior oversight.
Provide task-based mentoring to junior engineers and contract resources.
Required Qualifications
Bachelor's degree in science or engineering with 2+ years validation experience or equivalent.
Preferred Qualifications
Experience executing and authoring GMP validation documentation (IQ/OQ/PQ, cleaning, or process validation) for pharmaceutical or biotechnology manufacturing systems.
Working knowledge of FDA and EU GMP requirements, with experience supporting regulatory inspections or submission-related activities.
Ability to independently lead validation activities for simple or well-defined systems while contributing to complex projects under senior oversight.
Experience coordinating day-to-day activities of contractors or junior engineers supporting validation execution.
Demonstrated understanding of data integrity principles and validation lifecycle management.
Familiarity with computerized systems validation (CSV) and electronic records/electronic signatures requirements (e.g., 21 CFR Part 11 / EU Annex 11).
Experience working within an electronic quality management system (eQMS/eDMS), including document control, change control, and deviation management workflows.
Experience in biotechnology, cell therapy, or gene therapy manufacturing environments, or in startup/greenfield facilities.
Location and Working Environment
This role frequently requires periods of sitting, standing and physical activity in a regulated manufacturing environment that may on occasion require bending, stooping, and lifting objects or navigating equipment 5- 20lbs.
This position is based in Sanford, North Carolina and requires on-site work in a cGMP regulated manufacturing environment. Occasional travel (0-10%) may be required.
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
$82,880 - $118,400 (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 Sanford TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
