Responsibilities: 

• 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.