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Process Engineer

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for inhalers and Nasal Sprays.

Catalent Pharma Solutions in Morrisville, NC is hiring a Process Engineer. The Process Engineer is responsible for the execution of assigned activities for technical support and process validation related to new products, processes, equipment, and troubleshooting of current processes associated with Non-Sterile Liquids and Dry Powder Inhalation (DPI) Manufacturing. This role has routine interaction with manufacturing personnel, equipment engineering, and the other operational areas on site. The facility operates 24/5 with scheduled weekend work anticipated.

This is a full-time salaried position on 1st shift with core hours Monday-Friday, 8:00AM – 5:00PM. Minimal travel is required for this role.

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:

+ Execute assigned projects for the implementation of new processes and equipment, problem-solving for existing processes, process optimization, and process validation activities

+ Operational readiness of manufacturing equipment and facilities for commercial manufacture

+ Generate related documents, including Standard Operating Procedures (SOPs), Batch Documentation, Validation Plans, Protocols, and Evaluations

+ Provide technical and operational support to meet internal and external customer requirements

+ Support technology transfers from client or product development into the facility and, when applicable, to commercial manufacturing

+ Develop and progress continuous improvement initiatives

+ Gain an understanding of United States (US) and European Union (EU) requirements for manufacturing processes

+ All other duties as assigned - periodic weekend work to support manufacturing as required

The Candidate:

+ Candidate must have a Bachelor’s degree in Engineering, Life Science, or Pharmacy. Master’s degree or Lean Six Sigma Green Belt preferred

+ Must have at least two (2) years of experience working in clinical or commercial manufacturing

+ Must have ability to statistically analyze data in support of technical and regulatory documents

+ Preferred experience with Dry Powder Inhalation, nasal spray, and non-sterile processes. Ideal candidates would have experience with Root Cause Analysis and investigation/deviation support

+ **Physical requirements:** This position is in an office and manufacturing environment. Individual must be accessible to manufacturing areas and office staff and able to use required office equipment. Specific vision requirement includes reading of written documents and use of computer monitor screen frequently. Individual may be required to sit, stand, and walk regularly and lift up to 40 pounds. Must have the ability to wear a respirator

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 + 8 paid holidays

+ Several Employee Resource Groups focusing on D&I

+ Dynamic, fast-paced work environment

+ Community engagement and green initiatives

+ Generous 401K match

+ Company match on donations to organizations

+ 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 [email protected] . 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 [email protected] 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) .