Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
This Process Engineer is responsible for providing technical support, co-ordination and expertise for new technology introductions and other existing technologies to the Somerset site. This position will have direct responsibility for ensuring that GMP, Safety, and other regulatory considerations are clearly developed and implemented in the associated procedures, preventive maintenance records, engineering controls and maintenance processes. This position will develop key process engineering/maintenance data sets, spare parts procurement/control, FMEA studies, and process and facilities control mechanisms to develop performance optimization through the lifecycle of a project within Somerset.
Leads in providing innovative solution as they pertain to processing unit operations in the Somerset site focusing on process optimization, automation and efficiency across early stage development programs and/or late phase commercial.
Creates and monitor key equipment performance metrics such as equipment downtime and reject trends
Uses statistical thinking and methods to understand process variability and capability and drive process improvements.
Determines process capabilities and bottlenecks, implement improvements, and develop contingency plans for capacity/productivity increases.
Identifies failure modes of equipment and maintenance strategies to mitigate impact of failure.
Guides the specification and selection of manufacturing/utility equipment to support the process needs.
Responsible for the design and implementation of the process systems. Ensures this work meets cGMP (current Good Manufacturing Practices) expectations.
Works with operations, validation, process development and quality functions to provide support for the design, installation, start-up, validation and operation of facility and or process equipment.
BS or BA degree with concentrated studies in Engineering (Process, Mechanical, Chemical, Pharmaceutical) preferred with minimum 5+ years working with a cGMP manufacturing or pharmaceutical products facility
Alternatively, minimum 10+ years’ practical experience working with a cGMP manufacturing or pharmaceutical products facility that provide a working knowledge base of properties, theories, and manufacturing and packaging processes associated with manufacture and packaging of pharmaceutical products and contract manufacturing.
Knowledge within controlled release and Hot Melt Extrusion technologies is preferred
Basic knowledge of Lean Six Sigma and FDA cGMP’s preferred
Experience in Pharmaceutical industry preferred
Works cross-functionally and receives exposure to several departments
Medical, Dental, Vision and 401K are all offered from day one of employment
19 days of paid time off annually + 7 paid holidays
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.
personal initiative. dynamic pace. meaningful work.
Visit www.catalent.com/careers to explore career opportunities.
C atalent 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.