Quality Sr. Engineer, Computerized Systems Quality and Management (contract) - Vertex Pharmaceuticals

This position will be responsible for supporting the Quality Information Systems Management (QISM) group at Vertex, working closely with the operational functions and other Business/QA groups to facilitate requirements gathering, assessments, design, and system testing. This role will perform quality oversight functions and take quality ownership for all related computerized system projects.

The ideal candidate will be experienced working with computer systems, validation, and compliance in a GMP environment - specifically pharmaceuticals/biotech industries.

KEY RESPONSIBILITIES:        

• Proficient with Computerized systems on Enterprise Level, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projects.
• Take Quality ownership, participate in cross functional team discussions, provide quality guidance/decisions for the projects that includes New implementation, Enhancements, Quarterly releases, etc.
• Participate and Drive System Assessments, review and approve the project deliverables including plan, test scripts, execution and its outcome, reports, traceability.
• Participate and Drive the discussions on issues to the resolutions adhering to quality compliance.
• Sound knowledge on and Embrace Data Integrity integral to the system projects.
• Should poses good communication skills and fit as a team player.
• Highlight any identified quality risks and present possible mitigation options to the project team and keep informed to the quality management.
• Perform, evaluate, and communicate thorough quality assurance at every stage of systems development/implementation 

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in IT or Computer Science
• 5+ years of proven experience in computerized systems, Enterprise Level and Lab systems validation/quality capacity
• Familiarization with ITIL/GAMP5 Validation Lifecycle
• Proven analytical abilities
• Practical experience generating process documentation and reports
• Excellent communicator with the ability to translate data into actionable insights 

PREFERRED QUALIFICATIONS:

• Strong working knowledge of relevant computerized systems module, structure design
• Proven capabilities in project and user-testing management
• Proven development of innovative and impactful systems solutions
• Highly proficient technical writing capabilities
• Knowledge of Agile validation lifecycle and methodologies.
• Experience with ServiceNow and Application Lifecycle Management with e-signature (ALM) system is highly desirable.

$50-$55/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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No C2C or Third-Party Vendors