6513 - Senior Validation Engineer / Senior CQV Engineer

Socket.dev; Columbus (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Verista is seeking a Senior Validation / Senior CQV Engineer to author and execute commissioning, qualification, and validation documentation for standard equipment and software. You will run test scripts, maintain rigorous records, and ensure adherence to project schedules on regulated packaging operations in a life sciences setting.

The role requires a Bachelor’s degree plus 5+ years in validation-related activities; familiarity with GMP, QMS, and WORD/Excel tooling is expected.

Qualifications

• 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.

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.

Skills

Communication

Teamwork

Problem-solving

Time management

Attention to detail

GMP training

Word processing

Excel

PowerPoint

Education

Bachelor’s Degree or equivalent

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

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