Senior Validation Engineering Lead - Sterile Injectables

incog; Fishers (IN); On-site; USD 140,000 - 190,000; Full time

Job summary

INCOG BioPharma Services seeks a Senior Manager of Validation Engineering to lead CQV activities for sterile injectable operations. The role partners with clients on launches, audits and capital projects, while guiding validation strategy and regulatory submissions.

Requires extensive validation experience and strong leadership in a GMP environment. The position is based onsite in Fishers, IN, with a focus on driving continuous improvement and ensuring validated states across utilities,

Qualifications

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

Responsibilities

• Lead the Validation department with CQV activities for utilities, equipment and systems.
• Review and approve CQV lifecycle documentation.
• Develop and maintain validation lifecycle documents, templates and policies.
• Support site change management, risk assessment and GMP activities.
• Assess processing risks and define validation requirements.
• Interact with clients to provide validation support for launches and audits.
• Review regulatory filings and support health authority inspections.
• Oversee validation for capital expansion projects and CQV scheduling.
• Collaborate with Engineering and Operations to drive validation and process improvements.

Skills

CQV leadership

Validation expertise

Regulatory filings

Risk assessment

Cross-functional

Onsite supervision

Education

Bachelor’s degree in STEM

10+ years Validation

8+ years GMP

5+ years supervisory

Job description

INCOG BioPharma Services seeks a Senior Manager of Validation Engineering to lead CQV activities for sterile injectable operations. The role partners with clients on launches, audits and capital projects, while guiding validation strategy and regulatory submissions.

Requires extensive validation experience and strong leadership in a GMP environment. The position is based onsite in Fishers, IN, with a focus on driving continuous improvement and ensuring validated states across utilities,