Validation Process Engineer

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

Validation Process Engineer Position Summary

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

The Role

• 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 Requirements Specification (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Validation Summary Report (VSR), Configuration Qualifications (CQ), and Process Performance Qualifications (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.

The Candidate

• BS Engineering or relevant science degree required.
• 1 - 5 years of GMP process, equipment, and/or facility engineering validation experience.
• Client facing project management experience a 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 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 Requirements

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.

Why you should join Catalent

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

Join us in making a difference. personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.