Senior Quality Process Validation Specialist
INCOG BioPharma ServicesFishers, Indiana, United States
Posted March 10, 2026
Full Time
About the Company
INCOG BioPharma Services specializes in injectable drug product formulation development, analytical method development, process scale-up, and formulation & filling of vials, syringes, and cartridges. The company also offers customized packaging services including labeling, device assembly, final packaging, and integrated storage solutions at various temperature conditions. INCOG's expertise lies in providing comprehensive pharmaceutical solutions that meet the highest quality standards.
Job Description
INCOG BioPharma's Quality Assurance team is seeking a Senior Quality Process Validation Specialist to oversee process validation activities and ensure compliance with regulatory requirements.
Requirements
- Provide QA oversight and approval of process validation activities across all three stages of the process validation life cycle.
- Review and approve process validation life cycle documents, including risk assessments, process flow diagrams, and validation protocols.
- Ensure all process validation activities are performed in compliance with regulatory requirements, internal SOPs, and industry best practices.
Benefits
- Paid Time Off
- Retirement Plan
- Health Insurance