CSV Validation Engineer

Adverum is seeking a highly skilled Computer System Validation (CSV) Engineer to join our team. The CSV Engineer will be responsible for ensuring that all computer systems and software used comply with regulatory requirements and industry standards. This role involves planning, executing, and documenting validation activities to ensure the integrity and reliability of these systems.

What you'll do:

• Develop and implement validation strategies for computer systems and software applications.
• Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.
• Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.
• Conduct validation testing and review test results to ensure systems meet specified requirements.
• Provide training and support to staff on validation processes and procedures.
• Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance.
• Participate in audits and inspections by regulatory agencies.
• Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, BMS, EMS, & PCS.
• Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards
• Assist site Automation groups in configuring I/O and executing CSV protocol requirements.
• Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report

About you:

• Bachelor's degree in Computer Science, Engineering, or a related field.
• Minimum of 2-5 years of experience in computer system validation or a related field.
• Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).
• Experience with validation of various types of systems, including ERP, LIMS, and MES.
• Excellent documentation and technical writing skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.
• Preferred: Certification in Computer System Validation or related areas.
• Experience with cloud-based systems and software validation, experience with Blue Mountain RAM.

$90,000 - $110,000 a year

Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum's core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation

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