CSV Engineer

Fast-growing and innovative Biotechnology Company is seeking a CSV Engineer specialized in QMS to join their dynamic team This is a direct hire opportunity, allowing for hybrid work model. Must be able to go into the office at least twice per week

Responsibilities:

• Supports cGMP qualification and ISO 9001:2015 certification efforts.
• Assists in developing the computerized systems program.
• Collaborates with stakeholders to deploy and implement computerized systems, including LMS, EDMS, ERP, and software development.
• Maintains and improves computerized systems through procedure creation, review, and approval.
• Manages computerized system applications through validation, maintenance, quality administration, training, and process improvement.
• Executes documentation for CSA and CSV activities, including qualification and validation projects.
• Performs failure analysis, risk assessments, and problem-solving for system deficiencies and deviations.
• Conducts internal and external audits for system compliance with regulatory frameworks.
• Ensures compliance with relevant regulatory requirements such as GxP/GMP.
• Develops templates for risk assessments, user requirements, validation plans, and reports.
• Implements reporting tools for analysis, trending, and metrics.
• Assists in SOP, training material, and work instruction development.
• Acts as a liaison between QA and project teams to ensure regulatory compliance.
• Leads validation remediation strategy development for GxP systems.
• Manages, coaches, and trains project/internal resources as needed.
• Maintains inspection readiness and supports audit and inspection activities.
• Contributes to QMS initiatives as assigned.
• Provides QA approvals as needed.
• Takes on additional tasks and projects to meet business objectives.

Requirements:

• BA/BS with 7+ years of Pharma/Biotech Quality Management Systems (QMS).
• Experience with software, computerized systems, and/or control system validation.
• Experience with eQMS (EDMS, LMS, etc.). Experience with Veeva eQMS and CMMS is a strong plus.