Validation Engineer Job at Fagron (Wichita)

Validation Engineer

Fagron

Location:
United States , Wichita

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

The Validation Engineer is responsible for executing and maintaining validation programs that ensure facilities, equipment, utilities, and processes remain in a compliant, validated state within a 503B sterile manufacturing environment. This role supports new and existing operations through protocol development, data analysis, deviation management, and continuous improvement of validation lifecycle activities.

Job Responsibility:

Develop, execute, and maintain validation documents (IQ/OQ/PQ, PPQ, APS, CCIT, cleaning validation, equipment qualification, utility qualification)
Ensure validation activities comply with FDA 503B guidance, cGMPs (21 CFR Parts 210/211), and industry standards (USP <797>/<800>, ISPE, PDA)
Serve as validation SME for operations, engineering, quality, and new product introduction
Conduct and document validation-related investigations, including deviations, OOS, OOT, change controls, impact assessments, and CAPA root-cause analyses
Manage periodic review, revalidation, and continued process verification activities
Maintain calibration and preventative maintenance compliance for critical equipment and utilities
Support introduction of new equipment, closed systems, and aseptic technologies (e.g., single-use systems, isolators, automated filling systems)
Analyze validation data using appropriate statistical tools and prepare clear technical reports
Participate in regulatory inspections and defend validation lifecycle documentation
Stay current with regulatory expectations, emerging risks, and sterile compounding best practices

Requirements:

Bachelor’s degree in Engineering or a scientific discipline (or equivalent experience)
2–5 years of validation experience in pharmaceutical, sterile manufacturing, or 503B compounding
Strong understanding of aseptic processing, cleanroom classification, equipment/utility systems (HVAC, WFI/PW, compressed gases), and sterile filling operations
Experience with cGMP documentation, risk assessments, change control, and CAPA systems
Proficient in technical writing, data analysis, and cross-functional collaboration
Ability to work in a fast-paced, highly regulated environment with strong attention to detail

What we offer:

competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry

Additional Information:

Job Posted:
April 05, 2026

Employment Type:

Fulltime

Work Type:

On-site work

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Job Link Share:

Validation Engineer

Fagron

Location:
United States , Wichita

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 05, 2026

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