Validation Engineer II

Role Summary

The Validation Engineer II assists with the authoring, executing and reviewing of SOPs, commissioning documentation, and documents required for validation/qualification.

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 requalification's.
• 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.

Qualifications

• 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.

Skills

• Technical writing
• Verbal communication
• Project management
• Validation planning and execution

Languages

• English