Validation Process Engineer

Catalent; Kansas City (MO); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

152 hours of PTO

8 paid holidays

401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent’s Kansas City facility is hiring a Validation Process Engineer to support GMP validation activities across equipment and processes, from requirements through installation and verification. You will manage capital projects, author risk assessments, and coordinate training for operations and maintenance.

The role includes developing URS, supporting FAT/SAT, and ensuring compliance with cGDP/cGMP. Strong documentation skills and cross-functional collaboration are essential.

Qualifications

• BS Engineering or relevant science degree required.
• 1-5 years GMP validation experience in process/equipment/facility environments.
• Client-facing project management experience preferred.
• Lean Six Sigma training/certification preferred.
• Ability to write and execute validation protocols in compliance with cGDP and cGMP.

Responsibilities

• Develop User Requirement Specifications for new equipment and oversee procurement.
• Manage capital budgets and timelines to completion.

Skills

GMP validation

Process validation

Project management

Documentation

Regulatory compliance

Communication

Education

BS Engineering or relevant science degree

Job description

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.

Visit Catalent Careers to explore career opportunities.

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. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to [e-mail] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Volunteer Work Disclosure

Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.