CSV Engineer

Role: CSV Engineer

Rate: $40/hr. C2C

Location: Onsite in Warren, NJ

Visa: Any visa

Duration: 12 month

Client: Verista

We are seeking a skilled Computer System Validation (CSV) Specialist to support the commissioning and qualification (C&Q) efforts for a cell therapy manufacturing project. This role ensures that computer systems meet regulatory compliance standards and are validated to facilitate product manufacturing.

Responsibilities Include

• Develop and execute CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment
• Collaborate closely with automation and validation teams to ensure systems meet project and regulatory compliance standards
• Manage the document lifecycle, including creation, revision, and storage, in compliance with project documentation systems
• Participate in weekly project meetings to coordinate with system owners and management for alignment on project needs and issue resolution
• Conduct risk assessments and generate compliance reports, managing deviations and ensuring all required documentation meets quality and regulatory standards
• Oversee vendor interactions, including reviewing and tracking vendor deliverables and system qualifications
  
  

Requirements

• Bachelor's degree in a relevant field (e.g., Engineering, Computer Science, Life Sciences)
• Minimum of 5 years of experience in Computer System Validation in a GMP-regulated environment, ideally within pharmaceuticals or biotechnology
• Strong knowledge of regulatory compliance requirements (e.g., FDA regulations, cGMP standards) and quality systems
• Experience with DeltaV control systems and document management systems
• Excellent organizational, communication, and documentation skills
• Ability to work effectively both independently and as part of an integrated project team
• Must be available to work onsite at client site in Warren, NJ
• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
• Demonstrated ability to generate CSV deliverables independently
• Ability to work independently and as part of a team, with the ability to transition between the two
• Capacity to make independent sound decisions and independently manage priorities
• Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities
• 5 years minimum of relevant experience