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PharmEng Technology
Cary, NC | Full Time
$119k-145k (estimate)
2 Weeks Ago
Computer Systems Validation
$119k-145k (estimate)
Full Time | Business Services 2 Weeks Ago
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PharmEng Technology is Hiring a Computer Systems Validation Near Cary, NC

We are seeking a skilled Computer System Validation (CSV) Specialist with expertise in DeltaV software upgrades and DeltaV infrastructure validation. This role focuses on validating new hardware and software systems to meet site validation requirements, including the configuration of host hardware (HCI), virtual machine setup, and ensuring seamless integration with connected systems.

Key Responsibilities:

  • Perform computer system validation (CSV) specifically for DeltaV software (V15.LTS) upgrades and DeltaV infrastructure.
  • Configure and validate virtual machines and host hardware.
  • Ensure data migration from legacy systems to new platforms is accurate and efficient.
  • Verify integration and connectivity with systems such as OSI Pi, Acronis Backup and Recovery, and LogMate AMS.
  • Proficiency in CSV related to DeltaV software upgrades and DeltaV infrastructure (HyperV Hosting/VM qualification).

Scope of Services:

  • Provide support for commissioning and qualification activities focused on DeltaV systems.
  • Author and execute relevant commissioning and qualification documents, including:
    • User Requirement Specifications (URS)
    • Qualification Plans
    • Development Protocols
    • Specifications (Configuration, Software, Design, Functional)
    • Risk Assessments
    • Qualification Protocols (including deviation support)
    • Qualification Reports
  • Ensure alignment of design specifications with qualification strategy and procedures.
  • Stay informed about project updates, changes, and issues.
  • Attend meetings related to implementation, document reviews, and schedule reviews.
  • Track deliverables and milestones, escalating delays to Validation Management.
  • Report project or technical changes, issues, risks, and outstanding decisions to Validation Management

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$119k-145k (estimate)

POST DATE

05/26/2024

EXPIRATION DATE

07/25/2024

WEBSITE

pharmeng.com

HEADQUARTERS

DURHAM, NC

SIZE

200 - 500

FOUNDED

1997

CEO

ARI ATTILA

REVENUE

<$5M

INDUSTRY

Business Services

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