Validation Engineering Lead - GxP & Data Integrity

Ferring Pharmaceuticals Inc.; Roseville (MN); Presencial; USD 107.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare benefits

401(k) plan

Paid holidays

Descripción de la vacante

Ferring Pharmaceuticals Inc. is seeking an Engineering Supervisor to lead the Validation Engineering group and oversee equipment qualifications and computer system validation activities in a regulated biopharma setting.

You will partner with Quality, external vendors, and process owners to ensure risk-based validation, data integrity, and regulatory compliance across GMP operations. Leadership and continuous improvement are key to success in this role.

Formación

• Bachelor's degree in life sciences or equivalent experience.
• Minimum 5 years of experience overseeing Validation projects.
• In-depth knowledge of 21 CFR Part 11, Annex 11, GAMP 5 and Data Integrity concepts.
• 2+ years Supervisory or Lead experience.
• 5+ years in Biotech/pharma or regulated industries.

Responsabilidades

• Lead the Validation Engineering group to execute validations and equipment qualifications.
• Collaborate with Quality, vendors and end users to implement best practices.
• Perform gap analyses and drive corrective actions and continuous improvement.
• Support internal and external audits and regulatory inspections.
• Provide status updates to stakeholders and mentor direct reports.

Conocimientos

Regulatory knowledge (GxP)

Leadership

Data Integrity concepts

Risk-based validation

Communication

Educación

Bachelor's degree in life sciences

Herramientas

Word

Excel

PowerPoint

Access

Adobe Acrobat

Descripción del empleo

Ferring Pharmaceuticals Inc. is seeking an Engineering Supervisor to lead the Validation Engineering group and oversee equipment qualifications and computer system validation activities in a regulated biopharma setting.

You will partner with Quality, external vendors, and process owners to ensure risk-based validation, data integrity, and regulatory compliance across GMP operations. Leadership and continuous improvement are key to success in this role.