Validation Engineer
MedPharm
Durham, NC, USA
Posted on Oct 12, 2024
Job Purpose:
MedPharm is seeking a highly skilled and innovative Validation Engineer to join our expanding 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 a range of topical drug products. This position will collaborate closely with the formulation, production, and quality teams to ensure that the validation protocols meet regulatory standards and maintain product integrity.
Summary of Key Responsibilities:
MedPharm is seeking a highly skilled and innovative Validation Engineer to join our expanding 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 a range of topical drug products. This position will collaborate closely with the formulation, production, and quality teams to ensure that the validation protocols meet regulatory standards and maintain product integrity.
Summary of Key Responsibilities:
- Collaborate with manufacturing and packaging to develop and execute cleaning procedures and processes for cGMP equipment used in the manufacture of pharmaceutical products.
- Review Master Batch Records to evaluate 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.
- Bachelor’s degree in technical or life science.
- 5+ years of validation experience in pharmaceutical manufacturing.
- 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.