CSV Systems Engineer II/III jobs in United States
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Curia · 2 weeks ago

CSV Systems Engineer II/III

Curia is a global contract development and manufacturing organization focused on providing life-saving treatments. The CSV Systems Engineer will support Quality Management Systems and Computer System Validation efforts, ensuring quality teams have the necessary tools for audits and inspections.

BiotechnologyHealth CareManufacturing
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H1B Sponsor Likelynote

Responsibilities

Manage multiple site and global CSV projects at any time
Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
Create all CSV deliverables for all CSV projects
Provide expertise in SOP generation and CSV process
Own general configuration modification to any CSV system based on CSV compliance standards
Provide expertise on creation of CSV execution templates
Perform CSV risk assessments
Own CSV change records, CAPAs and Quality events for the CSV projects
Act as CSV reviewer on any CSV defects/deviations within any project
Support Site and global CSV actions from any audits
Participate in all site audits/inspections as CSV subject matter expert
Provide guidance and resolution on quality issues that affect the integrity of the data or the system
Gather inventory and maintain all scientific applications and computer systems within Curia sites (GMP and non-GMP)
Inform Service Engineer I of any changes in software and hardware status
Support Lab Ops team to ensure all computer systems has up to date Antivirus software
Support Lab Ops team to ensure all computer systems have a backup software installation
Support Lab Ops team in updating computer systems that are running outdated Operating systems
Perform monthly patching auditing risk assessments with Lead CSV Compliance Analyst
Execute periodic reviews and data collection
Participate in all site audits /inspections as a CSV subject matter expert
Provide routine project status reports
Provide routine software and hardware inventory updates
Provide routine progress updates on SOPs and Templates
Provide CAPA, QE and CR updates to compliance team
Provide routine audit observations and remediations

Qualification

Computer System ValidationQuality Management SystemsPharmaceutical Industry ExperienceSOP GenerationRisk AssessmentData IntegrityProject ManagementCommunication Skills

Required

Bachelor's Degree in Information Technology or related field
Minimum 3 years' experience in quality and computer systems validation and/or information technology

Preferred

Experience in the pharmaceutical industry

Benefits

Generous benefit options (eligible first day of employment)
Paid training, vacation and holidays (vacation accrual begins on first day of employment)
Career advancement opportunities
Education reimbursement
401K program with matching contributions
Learning platform
And more!

Company

Curia is a biotechnology company that offers discovery biology, synthetic, medicinal chemistry, and small-scale manufacturing services.

H1B Sponsorship

Curia 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 (34)
2024 (17)
2023 (8)

Funding

Current Stage
Late Stage
Total Funding
unknown
2025-03-07Debt Financing
2017-08-31Private Equity

Leadership Team

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Steve Lavezoli
Vice President, Biologics Division
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Company data provided by crunchbase