Onsite GMP Validation Engineer — Equipment & Projects

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

PTO & holidays: 152 hours + 8 holidays

Generous 401K match

Benefits from day one

Tuition Reimbursement

Job summary

Catalent Kansas City is seeking a Validation Process Engineer to oversee GMP equipment and process validation activities from requirements through installation, IQ/OQ/PQ and PPQ, with risk assessments and training support. The role emphasizes project management, documentation, and collaboration across operations, quality, and maintenance teams.

Ideal candidates have a BS in engineering or sciences and 1–5 years of GMP validation experience, plus strong communication skills and a Lean Six Sigma

Qualifications

• BS Engineering or relevant science degree required.
• 1 - 5 years of GMP process, equipment, and/or facility engineering validation experience.
• Lean six sigma training/certification, preferred.
• Demonstrated ability to write and execute technical documents and validation protocols in compliance with cGDP and cGMP requirements.

Responsibilities

• Develop User Requirement Specifications for new equipment and oversee build, and ensure that equipment meets functional requirements.
• Submit capital requests and manage project budget/timelines to completion.
• Support Factory Acceptance Tests (FAT), equipment installation, and Site Acceptance Tests (SAT) for equipment as needed.
• Prepare/execute/review FMEAs, Risk Assessments, PVs, VP, SIA, DIA, RS, DS, FRS, DQ, IQ, OQ, PQ, VSR, CQ, PPQ as required.
• Author Procedures and Work Instructions for equipment operation; coordinate and train operations and maintenance personnel.
• Perform periodic reviews and requalifications.
• Participate in site safety initiatives; contribute to continuous improvement projects.

Skills

Strong communication

Team collaboration

Documentation writing

Problem solving

Education

BS Engineering or relevant science degree

Job description

Catalent Kansas City is seeking a Validation Process Engineer to oversee GMP equipment and process validation activities from requirements through installation, IQ/OQ/PQ and PPQ, with risk assessments and training support. The role emphasizes project management, documentation, and collaboration across operations, quality, and maintenance teams.

Ideal candidates have a BS in engineering or sciences and 1–5 years of GMP validation experience, plus strong communication skills and a Lean Six Sigma