Validation Process Engineer

Disability Solutions - Kansas City, MO

Full-time - Entry Level

Kansas City, MO

Administrative and Support Services

About the position

Catalent PharmaSolutions in Kansas City, MO is hiring a Validation Process Engineer role. The Validation Process Engineer supports the identification and onboarding of equipment for both clinical and commercial operations and optimizes processes/equipment using lean six sigma (or equivalent), project management, and management of change tools. This role involves supporting the authoring of protocols/reports and managing the execution of equipment, freezer/cooler, utilities, facilities, cleaning, and process validation. The engineer will perform periodic validation reviews and re-validation activities. This position reports to the Engineering Manager and is a full-time role, working Monday to Friday during the day shift from 8:30 am to 5:00 pm. Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. The Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services, and Clinical Supply Services businesses, providing a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The site is a Center-of-Excellence for our Biologics Analytical Services business, with a talented team boasting over 25 years of experience in providing analytical services for both stand-alone and integrated biologics projects. The Validation Process Engineer will develop User Requirement Specifications for new equipment, identify equipment vendors, procure equipment, oversee build, and ensure that equipment meets functional requirements. Responsibilities include submitting capital requests and managing project budgets/timelines to completion, as well as preparing, executing, and reviewing Validation Plans (VP), System Impact Assessments (SIA), Requirements Specifications (RS), Design Specifications (DS), Functional Requirements Specification (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR) for equipment and critical systems and utilities. The engineer will also conduct Process Performance Qualification (PPQ) for the product manufacturing process and provide Release Authorization to release validated items into use. Additionally, the role involves designing and executing Performance Verification (PV)/Engineering Studies (ES), supporting Factory Acceptance Tests (FAT), equipment installation, and Site Acceptance Tests (SAT) as needed, and authoring Procedures and Work Instructions for equipment operation. The engineer will coordinate and train operations and maintenance personnel, identify and capture equipment key performance indicators (KPI), and perform risk assessments for safety hazards on all equipment, working with EH&S personnel to design appropriate hazard mitigation strategies. The role also includes understanding process flow, identifying bottlenecks, supporting GEMBA walks, and implementing efficiency improvements, as well as providing technical support for deviations and CAPAs and audits.

Responsibilities

• Support identification and onboarding of equipment for clinical and commercial operations.
• Optimize processes/equipment using lean six sigma or equivalent methodologies.
• Author protocols/reports and manage execution of equipment validation.
• Perform periodic validation reviews and re-validation activities.
• Develop User Requirement Specifications for new equipment and identify equipment vendors.
• Procure equipment and oversee build to ensure functional requirements are met.
• Submit capital requests and manage project budget/timelines to completion.
• Prepare, execute, and review Validation Plans (VP) and System Impact Assessments (SIA).
• Conduct Requirements Specifications (RS), Design Specifications (DS), and Functional Requirements Specification (FRS).
• Perform Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Execute Process Performance Qualification (PPQ) for product manufacturing processes.
• Design and execute Performance Verification (PV) and Engineering Studies (ES).
• Support Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for equipment.
• Author Procedures and Work Instructions for equipment operation.
• Coordinate and train operations and maintenance personnel.
• Identify and capture equipment key performance indicators (KPI).
• Perform risk assessments for safety hazards on all equipment.
• Work with EH&S personnel to design appropriate hazard mitigation strategies.
• Understand process flow and identify bottlenecks for efficiency improvements.
• Provide technical support for deviations and CAPAs and audits.

Requirements

• Bachelor's Degree preferably in Engineering or Life Sciences.
• 2+ years of experience with GMP equipment onboarding/validation/modification.
• Good communication and problem-solving skills.
• Working knowledge of Microsoft Outlook, Word, Excel, and Internet Explorer.
• Ability to work well with people of diverse cultures.
• Physical ability to sit, stand, walk regularly and occasionally lift up to 50 pounds.

Nice-to-haves

• Experience in a pharmaceutical or biotech environment.
• Familiarity with lean manufacturing principles.
• Project management experience.

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• 152 hours of PTO + 8 paid holidays.
• Several Employee Resource Groups focusing on D&I.
• Dynamic, fast-paced work environment.
• Positive working environment focusing on continually improving processes.
• Potential for career growth on an expanding team.
• Competitive salary.
• Community engagement and green initiatives.
• Generous 401K match and Paid Time Off accrual.
• Medical, dental and vision benefits effective day one of employment.
• Tuition Reimbursement.
• GymPass program to promote overall physical wellness.
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants.