Validation Specialist

4 weeks ago


Durham, North Carolina, United States MedPharm Full time
Job Title: Validation Engineer Job Summary: MedPharm is seeking a highly skilled and innovative Validation Engineer to join our team at our Durham facility. The Validation Engineer will be responsible for the development, execution, and report generation for qualification protocols. Validations will cover environmental, manufacturing, and packaging areas for a range of topical drug products. Key Responsibilities: Collaborate with manufacturing and packaging teams to develop and execute cleaning procedures and processes for cGMP equipment used in the manufacture of pharmaceutical products. Review Master Batch Records to evaluate the impact of chemicals and processes on the site's Cleaning Validation Program. Develop protocols to validate secondary packaging equipment. Ensure temperature mapping, environmental chambers, and controlled temperature areas are kept up to date and compliant. Experience commissioning equipment to support Drug Supply Chain Security Act (DSCSA) requirements. Regulatory Compliance: Ensure all packaging designs and processes comply with FDA, GMP, and other relevant regulatory requirements. Requirements: Bachelor's degree in a technical or life science field. 5+ years of validation experience in pharmaceutical manufacturing required. Experience with packaging for semi-solid and liquid formulations preferred. Familiarity with regulatory requirements for pharmaceutical manufacturing, including FDA, cGMPs, ISO, and ICH guidelines. Excellent problem-solving skills and the ability to work effectively in a fast-paced and dynamic environment. Working at MedPharm: At MedPharm, we are committed to providing a collaborative and dynamic work environment that fosters innovation and growth. Our team is dedicated to delivering high-quality products and services that meet the needs of our customers and stakeholders.
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