Validation Engineer

Job Summary Responsible for the validation of facility utilities and equipment processes for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Assist in authoring and executing protocols to demonstrate that manufacturing processes are executed with consistent quality and results within a controlled environment. Responsibilities Validate new and revalidate existing equipment used in OTC/Cosmetic and medical device manufacturing. Perform engineering studies to determine the feasibility of projects and support product/design transfer activities. Assist with measurement system analysis, including Gage R&R. Support change assessment activities, including assessment and qualification of changes to existing product components and implementation of products into manufacturing lines. Support root cause investigations for non-conformances related to manufacturing validations. Develop, prepare, and install equipment and revise test validation procedures/protocols to ensure a product is manufactured in accordance with regulatory agency validation requirements and current industry practices. Conduct IQ/OQ and PQ phases and implement validated SOPs. Coordinate projects directly with vendors and service providers to ensure all validation and installation requirements are satisfied during protocol execution. Develop project timelines, monitor progress, and update management and the team on status. Compile and analyze validation data, prepare reports, and recommend changes or improvements. Maintain all documentation pertaining to the qualification and validation of assigned projects and equipment/systems. Qualifications and Experience **Required Experience** Bachelor of Science Degree in Biology, Chemistry, or Engineering. At least 2 years of validation experience in a cGMP Device or Drug environment. Experience with validations of controlled environments or equipment in a regulated environment. Experience with validation documentation and related change control. Strong ability to manage multiple priorities, self‑starter attitude, good oral and writing skills, and the ability to work independently and as part of a team. **Preferred Qualifications** Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, Biomedical Engineering, or Engineering. Six Sigma certification. 3 years of validation experience in a cGMP Device or Drug environment. Process validation experience in a pharmaceutical or Medical Device manufacturing environment. Experience validating various product types such as liquid products, solid dosage products, and multi-component products. Experience in FDA regulated environments and with ISO 13485 and ISO 11607 standards. Experience with Measurement System Analysis and Minitab statistical analysis software. Experience with root cause analysis. Salary and Benefits Anticipated salary range: $73,000.00 – $110,000.00 per year. Salary will vary based on location, education, experience, and skills. This role is bonus and/or incentive eligible. The company will not pay less than the applicable minimum wage or salary threshold. Benefits include health insurance, life and disability, 401(k) contributions, paid time off, and access to employee assistance programs and resources for employees working 30 or more hours per week on average. For part‑time employees, benefits include 401(k) contributions, paid time off, and the Employee Assistance Program. EEO Statement Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. #J-18808-Ljbffr