Senior Biopharma Validation Engineer - PPQ Lead

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

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.