Validation Engineer

About the role

Our Business 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.

Location: Vandalia, Ohio

The Validation Engineer is a critical member of the Manufacturing Science and Technology team, and will have responsibility for Process Validation, Cleaning Validation, Facility Qualification, and Equipment Qualification.

Responsibilities

• Process Validation: Work on all aspects of manufacturing process validation and revalidation, including related change controls.
• Evaluate Critical Process Parameters and Critical Quality Attributes for new products.
• Create sampling and testing plan for each process validation protocol.
• Technical writing: Write process validation protocols and validation summary reports.
• Perform risk assessments of formulations and manufacturing processes.
• Document and close out deviations to protocol.
• Investigate causes for failing analytical results and process failures.
• Provides protocol training to Manufacturing and Quality Control personnel.
• Cleaning Validation: Work on all aspects of cleaning validation and verification, including related change controls.
• Validate the cleaning processes for new equipment and for the cleaning process in existing equipment after making new products.
• Maintain the ongoing annual cleaning verification program.
• Evaluate alternate cleaning agents and methods as needed and their potential impact on the validated status of cleaning processes.
• Technical writing for cleaning validation protocols and validation summary reports.
• Write evaluations of alternate cleaning