Validation Engineer

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. 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

Validation Engineer

Location

Vandalia, Ohio

Summary
In this position, the Engineer will utilize their formulations and/or technical services background to support Manufacturing. Responsibilities encompass technical knowledge in support of solid oral dose manufacturing. As a collaborative partner, they will utilize their expertise in all aspects of product scale up, contract manufacturing, validation and technical support of 3rd party manufacturing as well as internal support of solid oral dose facilities in North America.

Will be a key contributor and practitioner in lean manufacturing projects across multiple sites and manage various transfer and scale-up projects throughout the supply chain.

Responsibilities

• Manage scale up of commercial products, manufacturing feasibility batches, writing batch records and summarizing results for both internal and 3rd party manufacturing.
• Develop and execute studies for process, equipment, and cleaning validation activities related to bulk drug delivery and finished dosage formulations developed by Research and Development (R&D),products currently in commercial production, and technical transfers from customers or other Adare sites. These activities will be executed to Adare, customer, and regulatory, domestic and foreign, requirements.
• Provide technical training and support to departments supported by the Technical Services/Validation departments (Third party GSC, Manufacturing, etc).
• Update, review, and approve Standard Operating Procedures (SOPs), batch records, and other official documents and determine if validation or re-validation is required prior to approval of the new or changed procedure(s). Recommend new procedures or revisions as applicable.
• Participate in Factory Acceptance Testing (FAT) and/or due diligence testing and investigations.
• Collaborate with validation projects within the facility including execution of protocols and report writing.
• 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, 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.
• Support the engineering department with capital projects or trouble shooting of equipment and processes within the facility.
• Be a key contributor and practitioner of lean manufacturing programs within the facility.
• Attends work on a regular and predictable basis.
• Completes assigned tasks in a safe manner and in a constant state of alertness.
• Upholds Company policies, including the…