Job Description Process Engineer
Due to expansion, Catalent is looking to recruit an experienced Process Engineer to join a growing Manufacturing group at our site in Morrisville, NC.
The Manufacturing Department is responsible for the production of, inhaled products (MDI, pMDI, DPI, and nasal), sterile injectable mixtures 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.
This position 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 (daily 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.
- Develop and progress continuous improvement initiatives.
- Gain an understanding of US and EU requirement for manufacturing processes.
The Candidate (requirements)
- Bachelor’s degree in engineering, life science, or pharmacy and 5+ years applicable experience or equivalency in education and experience
- Commercial and Clinical Experience
- Direct experience with MDI and Sterile/Non-Sterile Processes or DPI manufacturing processes.
- Must be able to become Gown Room Certified
- Ability to statistically analyze data in support of technical and regulatory documents.
- Knowledgeable in cGMP’s and regulatory requirements
- Familiar with the activity sequence for process investigations and/or Root Cause Analysis
- Knowledgeable in principles of process validation and cGMP’s
- Potential for career growth within an expanding team
- Defined career path and annual performance review and feedback process
- Medical, Dental, Vision and 401K are all offered from Day One of employment
- 19 days of paid time off annually + 7 paid holidays
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.
Catalent. More products. Better treatments. Reliably supplied.™
Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493.
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
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.