Description

Process EngineerPosition Summary:<ul><li>Work Schedule: Monday - Friday, 8:00am to 5:00pm</li><li>100% on-site</li></ul>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:<ul><li>Execute assigned projects for the implementation of new processes and equipment, problem solving for existing processes, process optimization and process validation activities</li><li>Operational readiness of manufacturing equipment and facilities for commercial manufacture</li><li>Generate related documents including SOPs, Batch Documentation, Validation Plans, Protocols and Evaluations</li><li>Provide technical and operational support to meet internal and external customer requirements</li><li>Support technology transfer from client or product development into the facility and, when applicable, to commercial manufacturing</li><li>Other duties as assigned</li></ul>The Candidate:<ul><li>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</li><li>Prior Clinical and Commercial Process Engineering experience is preferred</li><li>Must have knowledge of cGMP’s and regulatory requirements</li><li>Knowledge and understanding of US and EU requirements for manufacturing is preferred</li><li>Must have proficiency in MS Office - Project, Word and Excel</li><li>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</li></ul>Why you should join Catalent:<ul><li>Defined career path and annual performance review and feedback process </li><li>Diverse, inclusive culture </li><li>Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives </li><li>152 hours of PTO + 8 paid holidays</li><li>Generous 401K match </li><li>Medical, dental and vision benefits</li><li>Tuition Reimbursement - Let us help you finish your degree or start a new degree!</li></ul>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 <a href="https://careers.catalent.com/us/en" target="_blank">Catalent Careers</a> 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 <a href="mailto:DisabilityAccommodations@catalent.com" target="_blank">DisabilityAccommodations@catalent.com</a>. 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 <a href="https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf" target="_blank">HERE</a>.

Process Engineer

Description

Catalent

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