CSV Engineer jobs in United States
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Lenmar Consulting Inc · 2 hours ago

CSV Engineer

Lenmar Consulting Inc is seeking a CSV Engineer to implement best practices and ensure compliance with regulations. The role involves project leadership, quality management, and continuous improvement within the context of site and process enhancement projects.

Information Technology & Services
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H1B Sponsor Likelynote

Responsibilities

Execute all responsibilities as the CSV owner for significant site and process improvement projects, ensuring compliance with regulatory requirements and industry standards
Perform all aspects of QMS processes, including Change Control, Deviations, and CAPAs
Manage Change Control specifically associated with DCS (DeltaV) and MES (Syncade) systems
Perform risk assessments on systems
Review change requests and test scripts
Draft validation protocols
Initiate and review GMP documentation revisions
Identify and implement industry best practices while maximizing process efficiency

Qualification

Validation ExpertiseTechnical SystemsIndustry ExperienceQuality ManagementDeadline ManagementRegulatory NavigationAttention to DetailIndependent Work

Required

Substantial experience in equipment and/or computer system validation (CSV)
Working experience with Controls Automation, Process Control Systems (PCS), Distributed Systems, and Manufacturing Execution Systems (MES)
Prior experience leading projects within the Biotech, Pharma, or Biologics industries
Strong attention to detail with the ability to work independently, manage deadlines successfully, and navigate complex regulations

Preferred

DeltaV experience

Company

Lenmar Consulting Inc

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Established in 1998, Lenmar’s Professional Services (Contingent/SOW Staffing & Managed Services) provides highly-skilled financial services professionals (contract/contract-to-hire/permanent) and helps clients to keep or bring back challenging projects in-house by bridging the technology and domain skills gap.

H1B Sponsorship

Lenmar Consulting Inc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (10)
2023 (8)
2022 (14)
2021 (16)
2020 (33)

Funding

Current Stage
Late Stage
Company data provided by crunchbase