Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries. https://www.youtube.com/watch?time_continue=1&v=65rz3LwTPX8
This employee will report directly to the Manager, CI Technology and Engineering
The position is a manufacturing core team leader supporting the commercial manufacturing process and equipment expansion, as well as ongoing operations. This position will be responsible for technical and operational elements of the new commercial inhalation manufacturing and CTM processes for packaging and this will include preparation and execution of validation protocols and troubleshooting. Also process improvement, equipment selection and usage, capacity utilization improvement, ensuring delivery to customer specifications and timelines, and customer, supplier and communications.
The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.
Active participation in equipment validation and qualification
Coordinate activities and project deliverables across operations.
Assemble, facilitate and participate in cross functional teams.
Define critical process parameters, operational ranges and acceptance for quality assurance and process validation activities.
Troubleshoot and resolve technical and/or program issues.
Incorporate EH&S in all design and process elements
Support serialization activities on all packaging lines
Bachelor's degree in Engineering or relevant discipline required with 10 years experience in pharmaceutical packaging operations in a cGMP environment.
Experience of maintenance and installation of manufacturing and packaging equipment.
Knowledge of change control and process validation is required.
Ability to assess risks (program, technical) and take appropriate corrective actions.
Strong problem solving and analytical skills in a process / manufacturing-based environment
Understanding of statistical process control, improvement methodologies and JMP or MiniTAB is preferred
Ability to work on a cross functional team to achieve a common objective.
Must possess appropriate broad communication skills allowing direct interaction with production employees, outside suppliers, internal stakeholders, and customers.
Leadership Competencies for Performance and Development
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, 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.