Validation Engineering Leader – Sterile Injectables

INCOG BioPharma; Fishers (IN); On-site; USD 130,000 - 185,000; Full time

Job summary

INCOG BioPharma in Fishers, IN seeks a Senior Manager of Validation Engineering to lead CQV activities for sterile injectables manufacturing and packaging. You will partner with internal and external customers to meet client project needs, capital expansion initiatives, and maintain validated state, influencing outcomes across the organization.

The role requires 10+ years in Validation with 8+ years GMP experience, plus 5+ years of supervision, and is onsite at our Fishers campus.

Qualifications

• Bachelor's degree or higher in a STEM discipline, preference in an engineering or life science discipline.
• 10+ years of experience in 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 associated systems (clean utilities, steam sterilization, depyrogenation, cleaning, filling, inspection, packaging and labeling).
• Review and approve CQV lifecycle documentation.
• Develop and maintain validation lifecycle documents, templates, validation strategies and policies.
• Support site change management, including risk assessment and GMP activities.
• Assess risks in processing steps related to equipment and validation requirements/design deliverables.
• Interact with clients to provide validation support including product launches, new equipment qualifications, audits.
• Review and provide technical expertise to regulatory filings and support health authority inspections.
• Support validation oversight for capital expansion projects and develop CQV schedules.
• Collaborate with Engineering and Operations to monitor validation and process improvement efforts.

Skills

CQV leadership

Validation engineering

Regulatory filings

GMP experience

Risk assessment

Project management

Client interaction

Onsite leadership

Education

Bachelor's degree in STEM

Engineering or life sciences degree

Job description

INCOG BioPharma in Fishers, IN seeks a Senior Manager of Validation Engineering to lead CQV activities for sterile injectables manufacturing and packaging. You will partner with internal and external customers to meet client project needs, capital expansion initiatives, and maintain validated state, influencing outcomes across the organization.

The role requires 10+ years in Validation with 8+ years GMP experience, plus 5+ years of supervision, and is onsite at our Fishers campus.