Validation Process Engineer

• ◆Work Schedule: M-F 8am-4:30pm
• ◆100% on-site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Validation Process Engineer. The Validation Process Engineer supports GMP equipment and process validation activities from

definition and vendor selection through installation, qualification, and performance verification to ensure systems meet user needs and regulatory expectations. Manages capital projects (budget, timelines, FAT/SAT) while authoring and executing risk assessments, validation protocols, and controlled documentation (e.g., IQ/OQ/PQ, PPQ, VSR) and coordinating training for operations and maintenance. Supports commercial client onboarding owning process capability assessments, FEMAs, validation master plans, process performance

and final product specifications. Provides technical support for change control, deviations/CAPA, audits, continuous improvement initiatives, and commercial client onboarding.

• ◆Develop User Requirement Specifications for new equipment, identify equipment vendors, procure 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, Performance Verifications (PV), Engineering Studies (ES), Validation Plans (VP), System Impact Assessments (SIA), Data Integrity Assessments (DIA), Requirement Specifications (RS), Design Specifications (DS), Functional

Specification (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Validation Summary Report (VSR), Configuration

(CQ), and Process Performance

(PPQ).

• ✓Author Procedures and Work Instructions for equipment operation. Coordinate and train operations and maintenance personnel.
• ✓Perform periodic reviews and requalifications.
• ✓Participate in site safety team initiatives.
• ✓Participate in Gemba Walks, Kaizens, Lean Six Sigma, and other continuous improvement projects/initiatives.
• ✓Lead and/or provide technical support for management of change forms (MOCs), deviations, change controls, CAPAs and audit findings.
• ✓Provide validation support for the onboarding of commercial clients.
• ✓Perform other duties as assigned.

to perform daily tasks in a regulated manufacturing environment.

• ✓Strong communication and collaboration skills, including written and verbal communication, presenting to groups (virtual and in person), and working effectively as part of a team to develop solutions.
• ✓Strong organizational, problem‑solving, and decision‑making skills, with the ability to manage multiple priorities, work under pressure, and apply a working understanding of basic machine functionality (e.g., PLCs, servo motors, controls, pneumatics).
• ✓Physical

Ability to stand, walk, sit, kneel, and reach frequently, occasionally lift, push, and pull up to 25 lbs, and climb ladders or steps as needed, while working in environments with temperature variation (including refrigerated and freezer areas), noise, humidity, and potential hazards; role also requires successful completion of background and DEA screening and up to 5% travel for trade shows and factory acceptance testing.