Process Engineer

Catalent Pharma Solutions • Morrisville, NC

10d • Onsite

About The Position

Process Engineer Position Summary: 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.

Requirements

• 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
• Must have knowledge of cGMP’s and regulatory requirements
• 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

Nice To Haves

• Prior Clinical and Commercial Process Engineering experience is preferred
• Knowledge and understanding of US and EU requirements for manufacturing is preferred

Responsibilities

• 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

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees