GMP Validation Engineer - Onsite Process Excellence

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

PTO + holidays

401K match

Benefits from day one

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Kansas City, MO is hiring a Validation Process Engineer. The role supports GMP equipment and process validation, from requirements to installation and performance verification, with capital project management and validation documentation creation.

The candidate should have 1–5 years of GMP validation experience, be able to write technical validation protocols, and collaborate with operations and maintenance.

Qualifications

• BS in Engineering or relevant science field required.
• 1-5 years GMP validation experience.
• Ability to read/write SOPs and regulatory requirements.
• Strong communication and teamwork.

Responsibilities

• Develop User Requirement Specifications for new equipment and oversee vendors to ensure functional meet.
• Submit capital requests and manage project budget/timelines to completion.
• Support FAT, equipment installation, and SAT for equipment when needed.
• Prepare/execute/review FMEAs, Risk Assessments, PV, ES, VP, SIA, DIA, RS, DS, FR_S, DQ, IQ, OQ, PQ, VSR, CQ, PPQ.
• Author Procedures and Work Instructions for equipment operation.
• Coordinate and train operations and maintenance personnel.
• Perform periodic reviews and requalifications.
• Lead management of change forms, deviations, CAPAs and audit findings.
• Provide validation support for onboarding of commercial clients.

Education

BS Engineering or relevant science degree

Job description

Catalent Pharma Solutions in Kansas City, MO is hiring a Validation Process Engineer. The role supports GMP equipment and process validation, from requirements to installation and performance verification, with capital project management and validation documentation creation.

The candidate should have 1–5 years of GMP validation experience, be able to write technical validation protocols, and collaborate with operations and maintenance.