Senior Quality Engineer

Senior CQV Engineer

Syracuse, NY, United States

Contract

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

• 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

Requirement

• 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.