Validation Engineer III

Role Summary

The Validation Engineer III is responsible for authoring, executing, and reviewing/approval of SOPs and commissioning documentation, and documents required for validation/qualification.

Responsibilities

• Oversees URS, protocols, reports & support records to ensure compliance, timely resolution of documentation, compliance, and quality system issues. Identify, coordinate, execute and provide oversight of validation activities related to the start-up, commissioning, qualification, validation of a cGMP manufacturing facility (including manufacturing equipment, QC lab equipment, utilities).
• Performs environmental mapping and other miscellaneous validation activities.
• Evaluates and analyzes validation data for accuracy and adequacy.
• Supports the development of validation execution strategy and timeline for sustained operation within validated GMP environment.
• Collaboratively conducts Risk Assessments and Impact assessments and establish system boundaries.
• Owns validation Lifecycle documents including Validation Plans, Impact Assessments, and Validation Reports.
• Reviews and supports Computer Systems Validation efforts for global systems.
• Manages workload to ensure timely approval of validation testing and documentation.
• Assists Quality Assurance, Production, Quality Control and other departments during inspections or audits.
• Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required to control financial and execution related aspects of project.
• Other related duties as assigned.

Qualifications

• BS/MS degree in Chemical, Industrial, Mechanical, or related engineering discipline; or Science with 5 years of relevant experience in the pharmaceutical or Biopharmaceutical industry (validation or engineering experience preferred).
• Experience with Biosafety cabinet smoke studies.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
• Experience supporting FDA approved, commercial products.
• Experience in cGMP environment (IQ, OQ, PQ) is essential.
• Familiar with current industry best practices, including ASTM e2500 to plan efficient/risk-based validation projects.
• Experience with validation tools and processes, including environmental mapping and use of Kaye Validator.
• Familiar with GAMP 5 applications and practices.
• Excellent technical writing and verbal communication skills.
• Proficient in Microsoft Word, Excel, PowerPoint, and Project.
• Experience providing technical support for problems of moderate scope where analysis requires a review of a variety of factors and able to drive toward issue resolution.

Skills

• Business Continuity.
• Change Control.
• Flexibility.
• General Hse Knowledge.
• HVAC (Heating, Ventilation and Air Conditioning).
• Including GDP.
• Installations (Computer Programs).
• Knowledge Of CAPA.
• Knowledge Of GMP.
• Manufacturing (Production).
• Project Commissioning.
• Project Engineering.
• Project Execution.
• Risk Management.
• Root Cause Analysis (RCA).

Languages

• English