Senior Process Engineer

Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines. By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind “Transforming Drug Delivery – Transforming Lives.” Our Culture When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space. In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day. Why Come to Adare? Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth. We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts ( medical and dependent care), and disability coverage. Position Senior Technical Services Engineer Location Vandalia, Ohio Summary The Senior Technical Services Engineer is a critical member of the Manufacturing Science and Technology team, and will focus on supporting commercial products. The main activities will be scale-up, technology transfer, process development, process optimization, process validation, troubleshooting, deviations, failure investigations, and technical writing. The Scientist will also participate in Lean Manufacturing and Operational Excellence projects. Responsibilities Manage scale-up, technology transfer, and process development of commercial products, manufacturing feasibility batches, writing batch records, protocols, and summarizing results for both internal and 3rd party manufacturing. Develop and execute studies for process, equipment, and activities related to bulk drug delivery and finished dosage formulations developed by Research and Development (R&D) and products currently in commercial production to Adare, customer, and regulatory (domestic and foreign) requirements. Support Manufacturing through process optimization, troubleshooting, deviations and failure investigations, batch record revisions, and report writing. Supports Manufacturing, Quality Assurance, and Regulatory Affairs in technical issues. Provide product impact assessments for deviations and investigations to QA and Regulatory Affairs. Technical writing: Write experimental protocols, process validation protocols, summary reports, batch records, deviations, and investigations. A main contributor and practitioner of Lean Manufacturing and Op Ex programs within the facility. Technical experience and/or expertise in the operation of pharmaceutical equipment including but not limited to tablet presses, blenders, fluid beds, roller compactors, pan coaters, mixers, drying ovens, capsule fillers, packaging equipment, and other pharmaceutical equipment. Operate independently and provide feedback and solutions to technical issues for both internal projects and projects at 3rd party sites. Provide technical training and support to departments supported by the Validation and Technical Services department (Third party GSQ, Manufacturing, etc.). Other duties as assigned Experience, Education, and Skills Required BS/BA degree from a four-year accredited university or college in Biology, Chemistry, Engineering, or related field; plus 5-8 years of related experience required. Ability to continually learn on the job: new equipment, new manufacturing technologies, new raw materials, etc. Problem solving and trouble-shooting abilities. Ability to determine the root causes of failures and problems. Capable of scientific observation of processes; has ability to accurately record observations and draw conclusions from them. Technical writing ability. Ability to explain scientific and technical issues to a non-specialist audience. Good working knowledge of “Good Manufacturing Practices”. Excellent interpersonal written and oral communication skills. Proficient in Microsoft Office – Word, Excel, PowerPoint, Visio. Experience with statistical software such as JMP is desirable. Ability to coordinate, contribute to, and work within cross-functional teams. Able to prioritize duties and work on multiple projects with minimal supervision. Possesses good attention to detail and excellent organizational skills. Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. Works in a cooperative manner with managers, supervisors, coworkers, customers, and the public. Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. #J-18808-Ljbffr Adare Pharma Solutions