Senior Validation Engineer: GMP Sterile Qualification

incog; Fishers (IN); On-site; USD 90,000 - 140,000; Full time

Job summary

INCOG BioPharma is seeking a Senior Validation Engineer to join the Validation Department at our Fishers, IN facility. The role focuses on qualification and validation of utilities, equipment and laboratory systems in a sterile injectables environment.

The candidate will develop SOPs, review facility changes, assess risks, and collaborate with Engineering and Operations to drive validation programs and continuous improvement. A STEM degree and 5–8 years of validation experience are required.

Qualifications

• Bachelor's degree or higher in STEM
• 5-8 years of experience in Validation or related discipline
• 4+ years GMP experience required or other regulated industry

Responsibilities

• Perform Qualification activities on utilities, equipment and laboratory systems.
• Interact with clients to provide validation support including customer product launches, new equipment qualifications.
• Support and provide validation oversight for capital expansion projects/build outs
• Develop and modify SOPs, Work Instructions, and guidelines for equipment validation policies, standards, procedures, and templates
• Review facility changes and provide input on re-validation and re-qualification of equipment
• Assess risks involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables
• Engage in cross-functional team and work with Engineering and Operations to support validation and process improvement efforts
• Conduct validation qualifications in accordance with all applicable protocols and identify associated protocol excursions.
• Identify industry trends in validation and regulatory expectations and propose program modifications

Skills

Validation expertise

GMP experience

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in STEM

Job description

INCOG BioPharma is seeking a Senior Validation Engineer to join the Validation Department at our Fishers, IN facility. The role focuses on qualification and validation of utilities, equipment and laboratory systems in a sterile injectables environment.

The candidate will develop SOPs, review facility changes, assess risks, and collaborate with Engineering and Operations to drive validation programs and continuous improvement. A STEM degree and 5–8 years of validation experience are required.