GMP Validation Engineer: Equipment & Process Owner

Catalent; Kansas City (MO); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

152 hours of PTO + 8 holidays

Generous 401K match

Medical, dental and vision from day 1

Tuition Reimbursement

Job summary

Catalent's Kansas City facility is hiring a Validation Process Engineer to drive GMP validation activities from requirements through qualification. You will manage capital projects, write validation protocols, and support FAT/SAT, with responsibility for training operations staff and coordinating change controls.

The role requires strong written and verbal communication, and the ability to work in a regulated manufacturing setting.

Qualifications

• BS Engineering or relevant science degree.
• 1-5 years GMP process, equipment, and/or facility engineering validation experience.
• Client-facing project management experience preferred.
• Lean Six Sigma training/certification preferred.
• Ability to write and execute validation protocols in compliance with cGDP and cGMP.

Responsibilities

• Develop User Requirement Specifications for new equipment and oversee procurement and build.
• Submit capital requests and manage project budgets and timelines.
• Support FAT/SAT and equipment installation and validation activities.
• Prepare and review validation documents (FMEA, PV, IQ/OQ/PQ, VSR, DQ, DS).
• Author procedures and train operations and maintenance staff.
• Perform periodic reviews and requalifications.
• Lead change controls, CAPAs, and audits.
• Support onboarding of commercial clients with validation expertise.

Skills

GMP validation

Project management

Technical documentation

Regulatory compliance

Communication

Education

BS Engineering or relevant science

Tools

FAT/SAT

IQ/OQ/PQ

Job description

Catalent's Kansas City facility is hiring a Validation Process Engineer to drive GMP validation activities from requirements through qualification. You will manage capital projects, write validation protocols, and support FAT/SAT, with responsibility for training operations staff and coordinating change controls.

The role requires strong written and verbal communication, and the ability to work in a regulated manufacturing setting.