We have an exciting opportunity for a client who is urgently hiring for a seasoned CSV Engineer who has direct experience implementing Veeva Quality System. If you enjoy implementing systems, using your CSV expertise to its full capacity, and engaging with stakeholders for key projects, let's set up a time to chat!

Job Responsibilities:

Establish Product Vision: Develop and maintain a clear, strategic product vision that aligns with both business objectives and customer needs.
Ensure Quality Compliance: Apply knowledge of quality systems within the life sciences sector to ensure adherence to industry standards and regulations.
Manage Product Backlog: Prioritize and manage the product backlog to ensure the most valuable and impactful features are delivered first.
Collaborate with Stakeholders: Partner with key stakeholders to gather requirements, address their needs, and integrate feedback into the product development lifecycle.
Guide Development Lifecycle: Oversee the product's journey from concept to release, ensuring all stages of development are efficiently executed.
Create and Refine User Stories: Act as the bridge between the GPO and SMEs, translating business requirements into actionable, testable user stories.
Define Acceptance Criteria: Set clear and concise acceptance criteria for each feature to ensure development teams understand what's required for success.
Monitor Development Progress: Track product development progress to ensure timelines are met, and quality standards are upheld.
Participate in Scrum Activities: Engage in Scrum meetings and sprints, providing progress updates, addressing blockers, and ensuring alignment with the overall product vision.
Document and Report: Prepare and present user requirements and system documentation, ensuring clear communication of product needs.
Develop Data Strategy: Design and implement a data strategy that supports the organization's immediate and long-term goals.

Job Qualifications:

Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related discipline.
Minimum of 10 years of experience in Computer System Validation (CSV) within a regulated environment (preferably pharmaceutical, biotech, or medical device).
Proven hands-on experience with the implementation of Veeva Systems.
Deep understanding of GAMP 5 methodology and FDA 21 CFR Part 11 compliance.
Proficient in developing and executing IQ/OQ/PQ protocols.
Experience with laboratory workflows and integrating Empower with analytical instruments.
Solid knowledge of change control, deviation management, and CAPA processes.
Strong grasp of data integrity principles and their application within QMS systems.
Exceptional written and verbal communication skills, with the ability to create documentation and conduct training.
Highly detail-oriented, with strong organizational and problem-solving capabilities.
Ability to work both independently and as part of a collaborative team.

Senior Quality Engineer

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