Catalent Pharma Solutions Process Engineer in Kansas City, Missouri
The Process Engineer supports both clinical and commercial operations including capital requests, equipment onboarding/qualification, process qualification, monitoring and optimizing process/equipment using lean six sigma (or equivalent), and project management.
Our newly hired Process Engineer will report to the Process/Equipment Engineering Manager at the Kansas City, Missouri Catalent site.
Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries. https://www.youtube.com/watch?time_continue=1&v=65rz3LwTPX8
The Role/Job Duties:
Develop User Requirement Specifications for new equipment or modification of current equipment and perform Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for equipment.
Identify key vendors to procure equipment, on-board the equipment, validate equipment and work through the CAPA process.
Design and execute Installation Qualification (IQ), Operational Qualification (OQ), Performance Verification (PV) and Process Performance Qualification (PPQ) protocols for equipment onboarding/modification/optimization.
Facilitate inclusion of all new or modified equipment into the site Total Productive Maintenance (TPM) program.
Monitor and report overall equipment effectiveness (OEE) metrics to senior leadership teams for capacity planning/management.
Perform regular Gemba walks with operations to identify lean improvement opportunities and provide technical support for deviations and CAPAs.
Education and Experience:
Engineering or relevant science degree required along with 2 - 5 years of experience with GMP equipment onboarding/validation/modification preferred.
Lean six sigma training/certification preferred.
Experience writing and executing validation protocols and SOPs.
Clear understanding of related SOPs and cGMPs as necessary to accomplish tasks.
Understands basic machine functionality (e.g. PLC’s, servo motors, controls, pneumatic function).
Communicates clearly with internal and external clients, both verbal and written.
We will identify candidates based on the following:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Join a high growth and fast paced organization with a people focused culture
Global exposure, defined career path and annual performance review and feedback process
Competitive Medical, Dental, Vision and 401K
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. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities, or contact us at
+1 877 503 9493.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
Grow with us. Be challenged. Make a personal impact.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.