Winchester, KY, 40392, USA
12 days ago
Process Engineer
**Process Engineer** **Position Summary** Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent's Winchester location is the flagship US manufacturing location for large scale complex controlled release (CR) oral dose forms, with integrated analytical and development services. With 20 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry leading Glatt technology. This site offers newly installed Fluid Beds, expanded analytical labs, and an advanced open facility design that provides flexibility in supporting the requirements of any new customer program. The Process Engineer is a member of the Site Engineering Team. The Process Engineer along with his team will drives the process and equipment improvement agenda as well as root cause analysis around process-oriented deviations for site operations. Regular working hours: Monday - Friday; 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. **The Role** + Process Monitoring: Create and monitor key equipment performance metrics such as equipment downtime and reject trends, Use 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. + Process Improvements: Identifies failure modes of equipment and maintenance strategies to mitigate impact of failure. + Design: Responsible for the design and implementation of the process systems. Ensures this work meets cGMP (current Good Manufacturing Practices) expectations. + Teamwork: Work 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. + Leadership: Will assist in synchronizing site functions through all phases of process improvements including new assets. + Safety: Ensures compliance to Health, Safety, and Environmental requirements is maintained throughout the project for area of responsibility. + Perform other duties as assigned. **The Candidate** + Minimum Bachelor’s degree in mechanical, Chemical or Electrical Engineering or working towards completing a Bachelor’s degree is required. + Communication: Ability to communicate effectively with engineers, technicians, customers, staff, and other personnel. + Technical Writing: Ability to provide detailed documentation in support of projects; includes business case analysis based on historical data or industry standards. + Technical Skills: Ability to troubleshoot simple to complex process and equipment problems. + Must be knowledgeable in the operation of common handheld and specialty tools and equipment. + Kneeling, squatting, crawling, sitting and other static postures required to be positioned in optimal placement for performing maintenance tasks. + Must be able to reach overhead, pushing, pulling and handheld tool use; Items including tools and lab equipment (1 to 15 lbs.), larger scale pieces of equipment involving multiple personnel for lift >50 lbs. + Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking. **Why You Should Join Catalent** + Several Employee Resource Groups focusing on D&I + Tuition Reimbursement – Let us help you finish your degree or earn a new one! + Generous 401K match + 152 hours accrued PTO + 8 paid holidays **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 Catalent Careers (https://careers.catalent.com/us/en) 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 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. 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 HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
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