Validation Process Engineer

$74,000 - $102,000/Yr

Catalent - Kansas City, MO

Full-time - Entry Level

Kansas City, MO

Chemical Manufacturing

About the position

Catalent Pharma Solutions in Kansas City, MO is hiring a Validation Process Engineer role. The Validation Process Engineer supports identification and on-boarding 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. The Validation Process Engineer supports author protocols/reports and manage the execution of equipment, freezer/cooler, utilities, facilities, cleaning, and process validation. Perform periodic validation reviews and re-validation activities. This position reports to the Engineering Manager. This is a full-time role position: Monday - Friday, Days. 1st Shift 8:30am-5:00pm. 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. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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 is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

Responsibilities

• Develop User Requirement Specifications for new equipment, identify equipment vendors, procure equipment, oversee build, and ensure that equipment meets functional requirements.
• Submit capital requests and manage project budget/timelines to completion.
• Preparation/Execution/Review of 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) and Performance Qualification (PQ), and Validation Summary Report (VSR) for equipment and critical systems and utilities, Process Performance Qualification (PPQ) for the product manufacturing process and Release Authorization to release validated items into use.
• Design and execute Performance Verification (PV)/Engineering Studies (ES). Support Factory Acceptance Tests (FAT), equipment installation, and Site Acceptance Tests (SAT) for equipment as needed.
• Author Procedures and Work Instructions for equipment operation. Coordinate and train operations and maintenance personnel.
• Identify and capture equipment key performance indicators (KPI) from equipment and qualified equipment parameters and settings while mitigating impact on change-over cycle times.
• Perform risk assessments for safety hazards on all equipment and work with EH&S personnel to design appropriate mitigation of hazards.
• Understand process flow, help identify bottlenecks, support GEMBA walks, and efficiency improvements and works with appropriate parties to provide corrective and preventive actions based on sound engineering analysis.
• Provide technical support for deviations and CAPAs and audits.
• All other duties as assigned.

Requirements

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

Nice-to-haves

• Experience with lean six sigma methodologies.
• Familiarity with project management tools and techniques.

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 to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 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 in a wide array of categories