- 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
- 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
- Must be willing to work onsite in Syracuse, NY
- Bachelor's Degree or equivalent required
- Demonstrated experience in leading CQV activities specific to facility, utility, and process equipment including autoclaves and fillers
- 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
- 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.
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Senior Quality Engineer - Syracuse, United States - Premier Life Sciences LLC
Description
Senior CQV EngineerSyracuse, NY, United States
Contract
Senior CQV Engineer Responsibilities: