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The Lead CSV Engineer/Analyst at Verista is responsible for authoring and executing technical documentation for system validation, conducting user interface testing, and collaborating with engineering teams to ensure compliance with industry standards. The role involves risk assessments and modifications based on testing results.
The Lead CQV Engineer/Analyst is responsible for authoring and executing commissioning, qualification, and validation documentation, running tests, and ensuring compliance with regulatory standards in pharmaceutical or biotech environments. This role includes leading CQV efforts in facilities and utilities, developing validation protocols, and conducting risk assessments while collaborating with engineering teams.
The Senior Quality Specialist will oversee quality processes for Cell and Gene Therapy operations, including batch disposition, quality investigations, and compliance with GMP regulations. Responsibilities include leading quality assurance efforts for manufacturing operations, reviewing documentation, providing training, and supporting change controls and CAPAs.
Process Engineers are responsible for supporting design, scale-up, product development, and operational improvements in pharmaceutical manufacturing environments. They investigate manufacturing processes, design and execute experiments, and write technical reports for process changes and regulatory filings. This is an entry-level position suitable for recent college graduates.
The Scrum Master will lead multiple Scrum teams in a transformation program, facilitating Agile delivery and managing product backlogs. The role includes coaching a junior Scrum Master and working closely with Product Owners to gather customer feedback. Experience in a regulated biopharma environment is essential, alongside strong communication skills.
The Automation Engineer will program and troubleshoot automated equipment like vision systems and Fanuc robotics, offering support during the equipment commissioning and qualification phases. They will assist site engineering initiatives, perform source code management, and ensure proper technical documentation and continuous improvement communication.
The Automation Engineer will manage the lifecycle of project-related documents for automation and commissioning, ensuring compliance with regulatory standards. Responsibilities include developing commissioning schedules, managing vendor interactions, conducting Factory and Site Acceptance Testing, and ensuring documentation aligns with Good Documentation Practices for audit readiness.
The CQV Engineer is responsible for authoring and executing qualification documentation, running test scripts, ensuring compliance with project schedules, and maintaining detailed records for validation processes. This role involves user interface testing, software verification, and making recommendations based on test results within a team setting.
The Senior Quality/GxP Auditor is responsible for developing compliance plans, consulting clients on best practices, mentoring team members, supporting audits, ensuring client compliance with regulations, and identifying areas for business expansion. The role requires strong communication skills and expert knowledge of GxP requirements.
The Senior Automation Engineer is responsible for the design and deployment of complex automated equipment. They program and configure products, troubleshoot PLC programming, and guide junior colleagues. The role involves testing, automation design challenges, and applying existing technology creatively to new applications.
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