Validation Manager

Astellas Pharma•Westborough, MA

5d•$105,280 - $150,400•Onsite

About The Position

The Validation Manager leads a team responsible for implementing and overseeing validation programs, policies, and procedures for facilities, utilities, equipment, analytical equipment, cleaning validation, and process performance qualification at AIRM/MA-TC’s cGMP Cell Therapy Manufacturing facility in Westborough, Massachusetts. The role provides validation leadership and subject-matter expertise for capital projects, establishes validation strategies, and manages validation project teams as products progress through clinical trials and commercialization. The manager oversees qualification and validation practices in alignment with global regulatory requirements, Astellas policies, and industry best practices. The role ensures critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and applicable regulatory guidance. It works closely with Manufacturing, Quality Control, Materials Management, Engineering, Cytogenomics, and Quality Assurance to maintain high quality standards and deliver value for patients. This position is based in Westborough, MA and requires on-site work, including frequent work in a cleanroom environment.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or Chemistry and at least 8 years of direct validation experience in a GMP-regulated industry; or a master’s degree and at least 5 years of direct validation experience. Candidates without a Life Sciences or equivalent degree may be considered with at least 10 years of industry experience in biotechnology or pharmaceutical quality, manufacturing, or another industry requiring high technical aptitude and attention to detail.
Experience as a people manager.
Strong knowledge of risk-based approaches to commissioning, qualification, and validation in a biotechnology manufacturing environment.
Demonstrated leadership, critical-thinking skills, and ability to influence across an organization to achieve milestones.
Knowledge of biotechnology cGMPs and working understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory requirements.
Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions and apply Quality-by-Design principles.
Fluency in deviation investigation techniques, root-cause analysis methods, CAPA effectiveness verification, and product-impact assessments.
Working fluency with Microsoft Office, including Excel basic formulas and creation and formatting of charts and data tables, and PowerPoint.
Solid technical writing skills and the ability to document work meticulously, accurately, and on time.
Strong written and oral communication skills and ability to work independently across departments to achieve validation milestones and deliverables.
Experience interacting with regulatory agencies, representing technical deliverables as a subject-matter expert, and hosting or supporting audits.

Nice To Haves

Specialized knowledge of industry-related topics such as bar coding, cell culture, auditing techniques, QC methods, or HEPA filtration science.
Experience overseeing Contract Manufacturing Organizations (CMOs) and related compliance considerations.
ASQ certification, such as certified quality engineer, quality auditor, or quality professional.
Experience with an electronic document management system.

Responsibilities

Manage and guide validation staff, supporting continuous improvement and the monitoring and maintenance of validation practices and records.
Own validation processes and present programs to regulatory inspectors and internal auditors during inspections and internal or partner audits.
Help establish validation program structures, including strategies, policies, procedures, and master plans.
Lead recurring validation forums and governance teams, manage overarching validation activities, and participate in capital-project resource planning.
Provide guidance on commissioning and qualification of facilities, utilities, equipment, automated systems, and process validation.
Author, execute, review, and approve validation documentation, and help resolve technical issues, evaluate results, and prepare reports.
Work with system owners, IT, and facilities engineering to ensure user and compliance requirements are tested and support requirements development for new equipment and systems.
Author, execute, and/or approve technical documents, including validation protocols and reports, user requirements, deviations, and risk assessments.
Manage contracted validation service providers, monitoring their performance and ensuring company requirements and business agreements are met.
Evaluate vendor qualification packages and create supplemental protocols when necessary.
Assess validation impacts from new systems and system changes using science-based quality risk assessments and applicable change-management policies.
Ensure data-integrity requirements are incorporated into facilities, utilities, equipment, automated systems, and process validation activities.
Use validation software, including Ellab ValSuite dataloggers, to perform mapping studies.
Maintain communication with manufacturing, facilities, and laboratory departments about validation issues and the validated state of equipment.
Ensure validation deliverables are completed on time and conduct periodic reviews of equipment and systems.
Lead development of testing strategies and rationales for equipment and systems.
Collaborate on quality events, including deviations and CAPAs, support investigations, and ensure quality records contain sound technical analysis, root-cause analysis, and risk assessments.
Serve as an organizational resource on Global Validation Strategy and ensure GMP operations comply with Astellas procedures and domestic and international GMP regulations.
Lead development of compliant validation processes and procedures for existing and new compliance requirements and support improvements to work practices.

Benefits

Medical, dental, and vision insurance.
Paid time off options, including vacation and sick time, plus national holidays and a year-end shutdown.
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.
Global collaboration and opportunities to contribute to patient-impacting therapies and scientific innovation.
A supportive environment that values employee contributions, development, and pursuing professional interests.