Senior Validation Manager GMP Biotech & Cell Therapy

Astellas; Westborough (MA); Sur place; USD 105 000 - 150 000; Plein temps

Avantages offerts par ce poste

Medical, Dental and Vision Insurance

Paid Time Off

401(k) match

Annual Corporate Bonus

Long Term Incentive Plan

Company fleet vehicle

Résumé du poste

Astellas is seeking a Validation Manager in Westborough, MA to lead a team responsible for validation programs across facilities, utilities, equipment and process validation in a cGMP cell therapy manufacturing setting. You will ensure compliance with FDA/EMA/ICH and internal policies, drive capital project validation oversight, and manage cross-functional collaborations.

The role requires strong leadership, extensive GMP validation expertise, and the ability to deliver timely validation

Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry with 8+ years of direct validation experience in GMP-regulated industry, or Masters with 5+ years of direct validation experience.
• Experience as a people manager with leadership capabilities.
• Strong knowledge of risk-based approach to commissioning, qualification, and validation activities in biotech manufacturing.

Responsabilités

• Manage a team of validation staff and ensure continuous improvement and documentation of validation records.
• Own validation programs and interact with regulatory inspectors during inspections and audits.
• Lead validation forums and governance teams and plan resource needs for capital projects.
• Provide guidance for commissioning and qualification of facilities, utilities, equipment, automated systems, and process validation.
• Author and approve validation documentation and resolve technical issues while communicating results clearly.

Connaissances

Team leadership

Validation

GxP knowledge

Regulatory compliance

Risk assessment

Data integrity

Cross-functional collaboration

Interdepartmental communication

Formation

BS/BA in Life Sciences, Engineering, or Chemistry

Masters degree in related field

Outils

Ellab ValSuite

Validation software

MS Office (Excel, PowerPoint)

Description du poste

Astellas is seeking a Validation Manager in Westborough, MA to lead a team responsible for validation programs across facilities, utilities, equipment and process validation in a cGMP cell therapy manufacturing setting. You will ensure compliance with FDA/EMA/ICH and internal policies, drive capital project validation oversight, and manage cross-functional collaborations.

The role requires strong leadership, extensive GMP validation expertise, and the ability to deliver timely validation