Job Details

Responsibilities:

• uthoring, 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.
• dherence with project schedule for all assigned activities.
• Maintaining clear, detailed records qualification and validation.
• Documenting impact and risk assessments as part of a team.
• Completing user interface testing, software verification, and complete alarm testing on automated systems.
• Developing, reviewing, and executing testing documentation.
• Making recommendations for design or process modification based on test results when executing test scripts.
• General understanding of capital equipment implementation and process knowledge.
• Understanding validation documents, URS, IQ, OQ, PQ.

• Bachelor's Degree or equivalent required.
• Must be willing to work onsite in Columbus, OH.
• Demonstrated experience in leading CQV activities specific to Process Equipment.
• Proficiency using PC and Microsoft Office tools.
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
• bility 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.
• 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.
• Experience with and tolerance for high levels of challenge and change.
• Experience in GMP regulated environment.
• Proven attention to detail and organization in project work.
• Capable of working on assigned tasks without mentorship.