Katalyst Healthcares and Life Sciences
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.