Validation Process Engineer

Position Summary

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.

The Role

• 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;

The Candidate

• Required a Bachelor’s Degree preferably in Engineering or Life Sciences.

• 2+ years of experience with GMP equipment onboarding/validation/modification highly preferred.

• Possess good communication and problem-solving skills highly desired.

• Working Computer 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.

Why you should join Catalent:

• 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

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .