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Senior Engineer, Quality Operations - Philadelphia Pennsylvania
Company: Disability Solutions
Location: Philadelphia, Pennsylvania
Posted On: 11/21/2024
Senior Engineer, Quality OperationsPosition Summary: Catalent is a global, high-growth, private 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.----This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging.-- Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.-- Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID--- safe storage labels for your studies. Single panel and Peel-ID--- safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.Catalent Pharma Solutions in Philadelphia is hiring a Senior Engineer, Quality Operations. This position reports to the Quality Assurance Manager and provides Quality Assurance guidance and support for activities related to Manufacturing and Packaging operations at Catalent Philadelphia.-- Supports regulatory compliance with FDA cGMPs, DEA requirements, Clinical Supply Services (CSS) Network Standard Operating Procedures, and Catalent CSS Philadelphia local Standard Operating Procedures. Responsible for performing/reviewing product quality complaint investigations, process deviations, and validation protocols.-- Responsible for overseeing special projects, compliance issues and providing possible corrective actions to remedy the issues and prevent future occurrences. The Senior Engineer, Quality Operations will have no direct reports.The Quality Assurance department is responsible for ensuring compliance with quality system and product quality requirements defined by international regulations and corporate, network, and local standard operating procedures.-- The Quality Operations department supports this by providing oversight and guidance on matters affecting the quality system or product quality in daily operations.This is a full-time, salaried role. ----This is onsite.-- This position is a 1st Shift role. The core hours are Monday - Friday, 8am-5pm.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: - Provides Quality Assurance (QA) support and oversight (including approval) for improvement projects, change requests, quality issue resolution, CAPAs, process control, validations, and data integrity assessments
- Understands and partners with Quality/Production/Project Management/ CI in the management and improvement of Quality-related metrics (Power BI), trending, strategic improvements as for deviations, complaints, change controls, etc
- Partners with Production personnel to encourage and implement a 'build in' Quality rather than 'inspect in' Quality culture
- Partners with Production/ Project Management to identify operating efficiencies to continuously improve and promote compliance
- Educates Quality/ Production/ Project Management on regulatory and customer requirements which impact upon the achievement of appropriate quality and compliance standards at the facility
- Drives, influences, and approves timely completion of product quality investigations, process or procedural deviations, and other quality system reports in TrackWise (as applicable), as well as timely review and approval of those reports completed by Production
- Support and promote improvement activities to lean the process through alignment of procedures reduction of waste, and a review of process with various statistical and non-statistical problem-solving tools as part of analysis
- All other duties as assignedThe Candidate:
- Requires a Bachelor's Degree with at least two years of relevant experience; OR an Associate's Degree with at least four years of relevant experience; OR a High School Diploma / GED with at least eight years of relevant experience OR ten years of relevant experience
- Required discipline of degree of Science or Engineering
- Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment is preferred
- Experience in a regulated, pharmaceutical field is strongly preferred
- Experience--working on continuous improvement activities in partnership with other functions (e.g. Production, Validation, etc.) is preferred
- Basic knowledge of Lean Six Sigma methodologies an advantage
- Challenges the status quo and understands and drives continuous improvement
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 poundsWhy You Should Join Catalent:
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