Senior Quality Engineer

3 weeks ago

Syracuse, United States Premier Life Sciences LLC Full time

Senior CQV Engineer

While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.

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.

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