Commissioning Qualification and Validation Engineer
Commissioning Qualification and Validation Engineer
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5years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Full time role
CQV Engineer
Columbus OH Onsite
CQV Engineer Responsibilities:
- Authoring editing and executing technical commissioning qualification and validation documentation for standard equipment/systems/ software and processes as part of a 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
- 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
Requirements
- Must be willing to work onsite in Columbus OH
- Bachelor s Degree or equivalent required
- Demonstrated experience in leading CQV activities specific to Process Equipment
At least 3 years experience/ knowledge with automated systems, including programming and improving complex systems Familiarity with at least one computer coding language (such as Python, Java, C#, HTML), understanding in version control systems (like GitHub or GitLab) is a plus Able to independently contribute through development and optimization of automation technologies preferred. Able to oversee implementation of automation technologies with third parties through technical skills and project management principles Must be able to work productively in an interdisciplinary team environment Experience with Hamilton, Scinomix, Tecan or similar automated laboratory platforms preferred Good oral and written communication, problem-solving, and analytical skills Ability to influence and educate other scientists and engineers to use automation technologies as part of implementation Proficiency using PC and Microsoft Office tools 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 Experience with and tolerance for high levels of challenge and change Experience with project management including capturing project requirements and deliverables, timeline development, stakeholder management and communications
Employment Type
Full Time
