Validation Process Engineer
Catalent Pharma Solutions
Summary
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.
Job description
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.
Requirements
- BS Engineering or relevant science degree required
- 1 - 5 years of GMP process, equipment, and/or facility engineering validation experience
- 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)
- Client facing project management experience a preferred
- Lean six sigma training/certification, preferred
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
- Paid Holidays
- Tuition Reimbursement
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.