What are the responsibilities and job description for the Quality Engineering & Validation Consultant position at United Pharma?
We are seeking an experienced Quality Engineering & Validation Consultant to provide GMP Quality oversight for manufacturing operations, validation activities, and capital projects in a biopharmaceutical environment. The ideal candidate will have strong experience supporting validation, investigations, CAPAs, and cross-functional quality initiatives.
Key Responsibilities:
• Provide Quality oversight for GMP manufacturing, validation, and engineering projects.
• Review and approve change controls, validation protocols, investigations, CAPAs, and risk assessments.
• Support equipment, facility, utility qualification, calibration, and preventive maintenance activities.
• Collaborate with Manufacturing, Engineering, Validation, Facilities, and QA teams to ensure GMP compliance.
• Drive quality improvements, support inspection readiness, and identify compliance risks.
• Support environmental monitoring and facility control systems.
Required Qualifications:
• BS in Engineering, Life Sciences, or a related field.
• 8 years of QA experience in pharmaceutical, biotech, or cell & gene therapy manufacturing.
• Strong experience with GMP validation, investigations, CAPAs, change controls, and risk assessments.
• Knowledge of aseptic manufacturing and equipment/facility qualification.