Engineer, Pharma Validation

🕒 July 30

🌽 Illinois – Remote

infoinfo

💵 $79k - $119k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👷🏻‍♀️ Engineer

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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

• Validate new and revalidate existing equipment used in OTC/Cosmetic manufacturing • Perform engineering studies to determine project feasibility • Develop, prepare, install equipment, and revise validation procedures and protocols • Develop and execute cleaning validations • Perform IQ/OQ and PQ phases • Coordinate with vendors and service providers to satisfy validation and installation requirements • Develop project timelines and ensure deadlines and goals are met • Update management and project teams on progress • Identify issues that may delay projects and recommend improvements to project timelines • Compile and analyze validation data, prepare reports, and recommend changes or improvements • Maintain documentation for qualification and validation of assigned projects and equipment/systems

🎯 Requirements

• 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 USP water, controlled environments or equipment validations in a regulated environment • Experience with validation documentation and related change control • Ability to manage multiple priorities • Ability to work independently and as part of a team • Strong oral and writing skills • Preferred: Master of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or related field • Preferred: Six Sigma certification • Preferred: 3 years of validation experience in a cGMP Device or Drug environment • Preferred: Validation experience in a pharmaceutical or medical device manufacturing environment • Preferred: Experience validating liquid products, solid dosage products, and multi-component products • Up to 40% international and domestic travel

🏖️ Benefits

• Competitive total rewards package • Continuing education & training • Health insurance • Life and disability insurance • 401(k) contributions • Paid time off • Employee Assistance Program • Employee Resource Groups • Employee Service Corp. • Bonus and/or incentive eligibility

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