Catalent Pharma Solutions in Kansas City, MO is hiring a Validation Engineer for the Clinical Services group. This person will 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 directly to the Manager, Planning and is responsible for writing/reviewing/approving protocols and reports for Process equipment, laboratory, process instruments, critical utility systems, computerized systems, facilities, and environmental control systems that directly impact product quality, as well you will be managing the execution of these protocols. This person will also perform periodic validation reviews and re-validation activities

This is a full-time position: Monday – Friday, 8:00AM-4:30PM.

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 facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and roller compaction.

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:

• Prepare, execute, and review 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.

• Develop/execute protocols for PPQs, cleaning validation, and facilities validation

• Evaluate changes to any validated systems, equipment, process, or procedure in terms of their effect on the state of validation through the change control program and in Compliance with the Quality System, using tools like Risk Assessment, FMEA, others.

• Works with appropriate parties to provide corrective and preventive actions based on sound engineering analysis.

• Write and Update SOP’s to ensure they meet all applicable regulatory requirements.

• Develop and review computer validation strategies including the development and review of computer validation documents such as user requirements specifications, validation plans, function, and design specifications, testing protocols, risk assessments, and validation summary reports, under FDA 21CFR11.

• Review and ensure all process, material, and procedural changes are appropriate and in compliance with regulatory requirements, ISO, and quality policies of the company.

• Review and ensure all qualification and validation documents are compliant with all applicable regulatory requirements and quality policies of the company.

• All other duties as assigned;

The Candidate:

• Bachelors of Science in Engineering, Science, or a related field required

• 3 or more years of direct validation experience in a GMP environment

• Knowledge and understanding of Pharmaceutical GxPs and excellent cGMP documentation skills

• Excellent written and verbal communication skills

• Statistical knowledge, DOE, and Quality Process Control experience preferred

• Proficient problem solving and decision-making skills

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 19 days of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Employee Stock Purchase Program

• 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 – Let us help you finish your degree or earn a new one!

• 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 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.

Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.