Validation Process Engineer

Work Schedule: Monday–Friday, 8:00 AM–4:30 PM. 100% on-site at Catalent’s Kansas City facility, which serves as a Center-of-Excellence for Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services. The site provides integrated services for oral solid dosage forms, including formulation development, analytical testing, and clinical/commercial-scale manufacturing.

About the role

The Validation Process Engineer supports GMP equipment and process validation activities—from requirements definition and vendor selection through installation, qualification, and performance verification—to ensure systems meet user needs and regulatory expectations. The role manages capital projects (budget, timelines, FAT/SAT), authors and executes risk assessments and validation protocols (e.g., IQ/OQ/PQ, PPQ, VSR), and coordinates training for operations and maintenance. The engineer also supports commercial client onboarding, including process capability assessments, FMEAs, validation master plans, process performance qualifications, and final product specifications. Additional responsibilities include technical support for change control, deviations/CAPA, audits, continuous improvement initiatives, and client onboarding.

Responsibilities

• Develop User Requirement Specifications for new equipment, identify vendors, procure equipment, and oversee build to ensure functional requirements are met.
• Submit capital requests and manage project budget/timelines to completion.
• Support Factory Acceptance Tests (FAT), equipment installation, and Site Acceptance Tests (SAT).
• Prepare, execute, and review validation documents, including:
  • FMEAs and Risk Assessments
  • Performance Verifications (PV) and Engineering Studies (ES)
  • Validation Plans (VP) and System Impact Assessments (SIA)
  • Data Integrity Assessments (DIA)
  • Requirement Specifications (RS) and Design Specifications (DS)
  • Functional Requirements Specifications (FRS)
  • Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Validation Summary Reports (VSR) and Configuration Qualifications (CQ)
  • Process Performance Qualifications (PPQ)
• Author Procedures and Work Instructions for equipment operation and coordinate training for operations and maintenance personnel.
• Perform periodic reviews and requalifications.
• Participate in site safety team initiatives, Gemba Walks, Kaizens, Lean Six Sigma, and other continuous improvement projects.
• 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.

Requirements

• Bachelor’s degree in Engineering or a relevant science field.
• 1–5 years of GMP process, equipment, and/or facility engineering validation experience.
• Client-facing project management experience (preferred).
• Lean Six Sigma training/certification (preferred).
• Demonstrated ability to write and execute technical documents and validation protocols in compliance with cGDP and cGMP requirements.
• Ability to read, understand, and apply SOPs and regulatory requirements in a regulated manufacturing environment.
• Strong communication and collaboration skills, including written and verbal communication, presenting to groups, and teamwork.
• Strong organizational, problem-solving, and decision-making skills, with the ability to manage multiple priorities under pressure.
• Working understanding of basic machine functionality (e.g., PLCs, servo motors, controls, pneumatics).

Physical Requirements

• Ability to stand, walk, sit, kneel, and reach frequently.
• Occasionally lift, push, and pull up to 25 lbs.
• Climb ladders or steps as needed.
• Work in environments with temperature variation (including refrigerated and freezer areas), noise, humidity, and potential hazards.
• Successful completion of background and DEA screening.
• Up to 5% travel for trade shows and factory acceptance testing.

Benefits

• Defined career path with annual performance review and feedback.
• Diverse, inclusive culture with a focus on continuous process improvement and innovation.
• 152 hours of PTO + 8 paid holidays.
• Generous 401K match.
• Medical, dental, and vision benefits effective on day one of employment.
• Tuition reimbursement for degree completion or new degree programs.