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Process Engineer

Position Summary

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 Pharma Solutions in Kansas City, MO is hiring a Process Engineer role. The Process Engineer serves as a Project Engineer, supporting 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. The Process Engineer position reports to the Manager, Process Engineering.

This is a full-time position: Onsite. 2nd Shift, Monday – Thursday : 12:30pm-11:00pm

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

• Responsible for ensuring Safety, Quality, Delivery and Costs are managed to meet project requirements

• Develop User Requirement Specifications for new equipment or modification of current equipment. Author Standard Operating Procedures and Work Instructions for equipment operation

• Successfully execute Capital projects through all phases including developing budget and scope, authoring required documents and forms for approval, purchasing equipment, overseeing installation of equipment and modifications of facilities, commissioning of equipment and closing out of project. Perform Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for more advanced equipment

• Design and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for equipment onboarding/modification/optimization

• Determine process capabilities and bottlenecks and implement improvements which have direct impact on efficiency

• Facilitate inclusion of all new or modified equipment into the site Total Productive Maintenance (TPM) program

• Support the on-going enhancement and optimization of manufacturing process systems by using a cGMP change management and software development lifecycle approach. Identify lean improvement opportunities and implement solutions to improve efficiency

• Participate in technical investigations for deviations as needed for equipment and processes. Complete corrections and actions when assigned

• All other duties as assigned;

The Candidate

• Required a Bachelor’s degree preferably in Chemical, Electrical, and Mechanical Engineering or Life Sciences with One+ years of experience in the Pharmaceutical or related manufacturing industry

• Basic understanding of machine functionality (e.g. PLC’s, servo motors, controls, pneumatic function highly desired

• Possess good communication and problem-solving skills highly desired

• Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required

• 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

• 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

• 152 hours of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Community engagement and green initiatives

• Generous 401K match

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

• WellHub- 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.

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) .