Validation Specialist II, Equipment

Responsibilities

• Work under general supervision to apply and grow validation expertise to resolve moderately complex issues
• Develop and execute protocols and summarize validation reports for equipment, computer systems, and processes
• Collect, compile, and analyze validation data to confirm the validated state of equipment for GMP use
• Participate on project teams to represent Validation internally
• Exercise judgment to determine appropriate action or recommend alternative solutions
• Communicate validation status effectively in writing and orally cross-functionally
• Contribute to department goals by leading small initiatives (limited resources and/or complexity)
• Support validation change control activities
• Revise validation SOPs and lifecycle validation documentation
• Perform equipment validation requalifications and periodic reviews (with general supervision)

• Bachelor’s degree in a scientific field
• 2+ years of relevant validation experience in a pharmaceutical/cGMP environment
• Working knowledge of Microsoft Office and email software
• Detail-oriented, self-motivated, organized; ability to prioritize
• Effective cross-functional communication with management and senior management
• Ability to adapt to change; ability to work with minimal supervision
• Ability to influence and may guide junior/support team members
• Working knowledge of validation data logger software (Amphenol/Ellab) for temperature/humidity mapping
• Working knowledge of Track Wise, Master Control, Blue Mountain RAM, and/or electronic document management systems
• Working knowledge of US FDA and EU regulatory requirements; communicate with regulatory agencies when applicable
• Ability to qualify Solid Dose, Dry Powder, API, Fill Finish, and/or Packaging processing equipment

• Ability to qualify QC/analytical equipment (HPLC, UPLC, spectrophotometers, LAL readers, TOC analyzers)
• Ability to qualify processing equipment (autoclaves, isolators, bioreactors, tanks, depyrogenation tunnel, blow-fill-seal, fluid bed granulator, tablet press/coaters, packaging lines, spray dryers, vision inspection systems)
• Ability to quality utilities (purified water systems, compressed air, nitrogen, HVAC, WFI system)

On-site at Silver Spring, Maryland 100% of the time; ~10% travel