Senior Validation Lead – CQV for Sterile Injectables

INCOG BioPharma Services; Fishers (IN); Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

INCOG BioPharma Services in Fishers, IN is seeking a Senior Manager of Validation Engineering to lead CQV activities for utilities, equipment and related systems in a sterile injectables facility.

The role requires 10+ years in validation, 8+ years GMP or regulated industry experience, and at least 5 years of supervisory leadership. Onsite work is required, with opportunities to influence capital projects and regulatory interactions.

Qualifikationen

• Bachelor’s degree or higher in a STEM discipline.
• 10+ years of experience in Validation or related discipline.
• 8+ years GMP or other regulated industry experience.
• 5+ years of supervisory experience.
• Physically capable of working onsite.

Aufgaben

• Lead the Validation department with CQV activities for utilities, equipment and related systems.
• Review and approve CQV lifecycle documentation.
• Develop and maintain validation strategies and lifecycle templates.
• Support site change management including risk assessment and GMP activities.
• Assess risks in processing steps and validate requirements and design deliverables.
• Interact with clients to provide validation support for product launches and audits.
• Support regulatory filings and health authority inspections.
• Oversee validation for capital expansion projects and develop CQV schedules.

Kenntnisse

Leadership

Client interaction

Risk assessment

CQV

Regulatory understanding

Ausbildung

Bachelor’s degree in STEM

Jobbeschreibung

INCOG BioPharma Services in Fishers, IN is seeking a Senior Manager of Validation Engineering to lead CQV activities for utilities, equipment and related systems in a sterile injectables facility.

The role requires 10+ years in validation, 8+ years GMP or regulated industry experience, and at least 5 years of supervisory leadership. Onsite work is required, with opportunities to influence capital projects and regulatory interactions.