Senior Validation Engineer

Supports the development of Validation/Qualification documents including drafting risk assessments, qualification protocols, deviations, and reports. Supports the execution of validation/qualification activities for the site (including manufacturing equipment, QC lab equipment, utilities). Reviews, evaluates, and analyzes validation data for accuracy and adequacy. Supports the validation execution strategy and timeline for sustained commercial and clinical operations within a validation GMP environment. Assists with change management validation impact assessments. Supports the site validation periodic re-evaluation program including periodic reviews and requalifications. Assists with Validation lifecycle documents. Manages workload to ensure timely approval of validation testing and documentation. Supports the validation department during inspections or audits. Other related duties as assigned.

Requirements:- BS/MS degree in Chemical, Industrial, Mechanical, or other related engineering/science discipline with a minimum of 2 years of relevant engineering experience in the pharmaceutical or Biopharmaceutical industry.- Familiarity with good engineering practices, validation tools and processes, risk management, GAMP 5 applications and practices (including environmental mapping and use of Thermal Mapping equipment is preferred).- Experience in cGMP environment (IQ, OQ, PQ).- Familiar with current industry best practices, including ASTM e2500 to plan efficient/risk-based validation projects.- Strong technical writing and verbal communication skills.- Proficient in Microsoft Word, Excel, PowerPoint, and Project.