Catalent Pharma Solutions Process Engineer in Morrisville, North Carolina
The Manufacturing Department is responsible for the production of, inhaled products (MDI, pMDI, DPI, and nasal), and other formulations compatible with the equipment available at the Catalent Morrisville site. This includes maintenance, setup, operation, changeover, and routine maintenance of automated and manual production equipment. The Manufacturing Department executes, completes, all associated master batch record documentation; creates and reviews standard operating procedures; creates manufacturing metrics documentation and assists with process development and validation studies.
The Role (daily responsibilities)
This position is responsible for the execution of assigned activities for technical support, scale up and process optimization 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, facilities, project engineering, product development and the other operational areas on site
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, Engineering Study Plans, Protocols and Evaluations.
Process Optimization and continuous improvements on the existing process trains.
Provide technical and operational support to meet internal and external customer requirements.
Analyze production data and generate regression analysis elements that affect product characteristics
Perform engineering studies using various tools such as Design of Experiments in order to determine the optimal operating ranges
Support technology transfer from client or product development into the facility and, when applicable, to commercial manufacturing.
Support process validation studies.
Develop and progress continuous improvement initiatives.
The Candidate (requirements)
Bachelor’s degree in engineering preferred 5+ years applicable experience or 3+ years applicable experience with a post graduate studies in pharmaceutical sciences or equivalent.
Knowledgeable in principles of process and equipment validation and cGMP’s
Must be able to become Gown Room Certified
Direct experience with statistical tools such as JMP or Minitab
Ability to statistically analyze data in support of technical and regulatory documents.
Knowledgeable in cGMP’s and regulatory requirements
Good written and oral communication skills
Familiar with the activity sequence for process investigations and/or Root Cause Analysis
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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.
Catalent. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
Grow with us. Be challenged. Make a personal impact.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.