Validation Process Engineer

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

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.

[e-mail] - 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.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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