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Sr CSV Engineer- MUST have Biotech/Pharma experience
Connexion Systems & Engineering - Boston, MA
posted 2 months ago
About the position
The Quality Senior Engineer, Computerized Systems Quality and Management role is focused on supporting the Quality Information Systems Management (QISM) group within a biotech/pharma environment. This position involves collaborating with operational functions and other Business/QA groups to facilitate requirements gathering, assessments, design, and system testing. The engineer will take ownership of quality oversight for computerized system projects, ensuring compliance and data integrity throughout the systems development lifecycle.
Responsibilities
- Provide quality oversight on computerized systems at the enterprise level, lab systems, and manufacturing systems.
- Take quality ownership and participate in cross-functional team discussions, providing quality guidance for new implementations, enhancements, and quarterly releases.
- Drive system assessments and review project deliverables including plans, test scripts, execution outcomes, reports, and traceability.
- Facilitate discussions on issues and resolutions while adhering to quality compliance.
- Embrace data integrity principles integral to system projects.
- Communicate identified quality risks and present mitigation options to the project team and quality management.
- Perform thorough quality assurance evaluations at every stage of systems development and implementation.
Requirements
- Bachelor's degree in IT or Computer Science.
- 5+ years of proven experience in computerized systems, enterprise level, and lab systems validation/quality capacity.
- Familiarity with ITIL/GAMP5 Validation Lifecycle.
- Proven analytical abilities and practical experience generating process documentation and reports.
- Excellent communication skills with the ability to translate data into actionable insights.
Nice-to-haves
- Strong working knowledge of relevant computerized systems module and structure design.
- Proven capabilities in project and user-testing management.
- Experience in developing 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.
Benefits
- Competitive hourly pay of $50-55/hr
- Hybrid work environment in Boston, MA
