6513 - Senior Validation Engineer / Senior CQV Engineer

Senior Validation / Senior CQV Engineer Responsibilities:

• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed records qualification and validation
• Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment

Requirements:

• Bachelor’s Degree or equivalent required
• 5+ years of experience authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software,
• Prior experience supporting validation, qualification, or testing activities for packaging equipment or packaging lines preferred
• Experience working in or supporting pharmaceutical, medical device, combination product, or regulated packaging operations is a plus
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice training (may be completed at onboarding)
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities