Engineer, Pharma Validation

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🔥 23 hours ago

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Logo of Medline Industries, LP

Medline Industries, LP

10,000+ employees

Founded 1910

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 Private Equity Round on 2021-06

Healthcare • Logistics • Manufacturing

Medline Industries, LP is a leading healthcare company that focuses on improving clinical, financial, and operational outcomes for its customers. The company offers a wide array of over 335,000 medical products and boasts extensive warehousing capabilities with more than 28 million square feet of space. With a significant global presence of 43,000 employees, Medline provides agile and scalable solutions across all points of care, achieving a 95% next-day delivery rate within the US. The company's mission is to enhance healthcare delivery by providing superior products, supply chain resilience, and clinical expertise, all while fostering strong customer relationships through tailored, problem-solving solutions.

📋 Description

• Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products • Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic manufacturing • Perform engineering studies to determine if projects are feasible • Develop, prepare and install equipment and revise test validation procedures/protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices • Develop and execute cleaning validations • Responsible for IQ/OQ and PQ phases • Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols • Develop timelines for all projects and ensure that deadlines and goals are being met • Frequently update management and team on progress • Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion • Compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements • Maintain all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems.

🎯 Requirements

• Bachelor of Science Degree in Biology, Chemistry or Engineering • At least 2 year of validation experience in a cGMP Device or Drug environment • Experience with validations of USP water, controlled environments or equipment validations 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 a team in an efficient manner.

🏖️ Benefits

• health insurance • life and disability insurance • 401(k) contributions • paid time off

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