Senior Validation Engineer – Sterile Injectables

INCOG BioPharma Services; Fishers (IN); On-site; USD 95,000 - 135,000; Full time

Job summary

INCOG BioPharma is seeking a Senior Validation Engineer to lead qualification and validation for a sterile injectables facility. You will partner with clients, operations and engineering to ensure compliant product launches and capital projects.

This role requires 5–8 years in validation, GMP experience, and a Bachelor's in STEM. Onsite work in Fishers, IN is expected with collaboration across teams.

Qualifications

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

Responsibilities

• Perform Qualification activities on utilities, equipment and laboratory systems.
• Interact with clients to provide validation support including product launches and new equipment qualifications.
• Support and provide validation oversight for capital expansion projects or build outs.
• Develop and modify SOPs, WIs and templates for equipment validation policies and procedures.
• Review facility changes and input on re-validation and re-qualification of equipment.
• Assess risks in processing steps and develop validation requirements and deliverables.
• Collaborate with Engineering and Operations to monitor validation and process improvements.
• Conduct validation qualifications in line with applicable protocols and identify excursions.
• Track industry trends and adjust programs to meet regulatory expectations.

Skills

Validation

GMP experience

Qualification

Regulatory experience

Education

Bachelor's degree in STEM

Master's degree (preferred)

Job description

INCOG BioPharma is seeking a Senior Validation Engineer to lead qualification and validation for a sterile injectables facility. You will partner with clients, operations and engineering to ensure compliant product launches and capital projects.

This role requires 5–8 years in validation, GMP experience, and a Bachelor's in STEM. Onsite work in Fishers, IN is expected with collaboration across teams.