Catalent

Process Engineer

Catalent  •  Morrisville, NC (Onsite)  •  12 days ago
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Job Description

Process Engineer

  • Work Schedule: Monday - Friday, 8:00am to 5:00pm
  • 100% on-site

The Morrisville (MSV) facility is Catalent’s center of excellence for nasal product development and manufacturing, providing end‑to‑end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing.

The Process Engineer is responsible for the execution of assigned activities for technical support and process validation related to new products, process, equipment and troubleshooting of current processes associated with Metered Dose Inhalers Sterile/Non-Sterile Liquids and Dry Powder Inhalation Manufacturing. This role has routine interaction with manufacturing personnel, equipment engineering and the other operational areas on site.

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 SOPs, Batch Documentation, Validation Plans, Protocols and Evaluations
  • Provide technical and operational support to meet internal and external customer requirements
  • Support technology transfer from client or product development into the facility and, when applicable, to commercial manufacturing
  • Other duties as assigned

The Candidate:

  • Must have a Bachelor’s Degree; Preferred fields of study, Engineering, Life Science or Pharmacy and 5+ years of relevant experience OR equivalent combination of education and experience
  • Prior Clinical and Commercial Process Engineering experience is preferred
  • Must have knowledge of cGMP’s and regulatory requirements
  • Knowledge and understanding of US and EU requirements for manufacturing is preferred
  • Must have proficiency in MS Office - Project, Word and Excel
  • On an average 8 hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds

Why you should join Catalent:

  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
  • 152 hours of PTO + 8 paid holidays
  • Generous 401K match
  • Medical, dental and vision benefits
  • Tuition Reimbursement - Let us help you finish your degree or start a new degree!

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 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

Catalent

About Catalent

Championing the missions that matter™. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) and trusted partner to pharma, biotech, and consumer health companies worldwide. We put patients first in everything we do, helping people live better and healthier lives through every product we help develop, manufacture and deliver. With over 1,000 active development programs at any given time, we launch over 100 new products and line extensions annually. Catalent has supported half of all FDA approvals over the past decade, and our teams working at over 40 global sites help us produce over 60 billion doses every year.

Our strength lies in our people: teams across our more than 40 sites and thousands of passionate scientists and technicians who bring expertise in development sciences, delivery technologies, and multi-modality manufacturing. What unites us is our commitment to championing our partners’ missions as our own, anticipating customer needs, solving complex challenges and ultimately making a difference in the lives of patients across the globe.

At Catalent, you will be able to directly have an impact, solving problems and ensuring excellence for our customers. Our focus on delivering meaningful outcomes alongside our customers means your work directly impacts millions of people around the world. Join us in championing the missions that matter.

Catalent is headquartered in Tampa, Florida, with over 40 global sites. Visit www.catalent.com to learn more.

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Tampa, Florida
Year Founded
Unknown
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