urs Jobs in north carolina

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C&Q Engineer

Sunrise Systems, Inc.

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Wilson, North Carolina, USA

Contract

Job Title: C&Q Engineer Job ID: 25-09377 Location: Wilson, NC 27893 Duration: 17 Months On W2 Contract Job Purpose The C&Q Engineer is responsible for the execution of the defined C&Q scope of the following areas Black Utilities and HVAC. These are Client-side roles and key responsibilities are meeting the agreed objectives regarding time, schedule and functionality according to EHS, URS and GMP requirements. The C&Q Engineer SME is responsible for planning and executing commissioning activit
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Posted 12 days ago | Updated 21 hours ago

Compliance Lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 6 days ago | Updated 1 day ago

C&Q Engineer

Katalyst Healthcares and Lifesciences

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Wilson, North Carolina, USA

Full-time

Job description: The C&Q Engineer is responsible for the execution of the defined C&Q scope of the following areas - Black Utilities and HVAC. These are Client-side roles and key responsibilities are meeting the agreed objectives regarding time, schedule and functionality according to EHS, URS and GMP requirements. The C&Q Engineer SME is responsible for planning and executing commissioning activities related to all equipment groups within their area. Reporting to the Client C&Q Manager. Plannin
Posted 6 days ago | Updated 1 hour ago

CQV Engineer

Katalyst Healthcares and Lifesciences

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Holly Springs, North Carolina, USA

Full-time

Responsibilities: Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC). Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis. Supporting clients change management program - including authoring proposed changes, executing impact assessments/ regression analysis,
Posted 13 days ago | Updated 1 hour ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 28 days ago | Updated 1 hour ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 1 hour ago

Pharmacovigilance Business Analyst

Cygnus Professionals

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Remote

Full-time

Position Title: Pharmacovigilance Business AnalystLocation: Remote Duration: 12 plus months contract or Fulltime Requirements: Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field.Minimum 10+ years of Business Analyst experience is required.Clinical Trial domain expertise, including Study Execution, Site Monitoring, Data Management, and Patient Safety.Exposure to Pharmacovigilance, and Quality and Compliance processes preferred.Experience with SQL and
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Posted 20 days ago

MES Engineer - Sanford, NC. Hybrid, 3-4 days onsite/ week - Needs exp. with Rockwell PharmaSuite*

Sedna Consulting Group

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Charlotte, North Carolina, USA

Third Party, Contract

Dear Applicant, Please let me know if you are interested. Job Title - MES Engineer Location - Sanford, NC. Hybrid, 3-4 days expected onsite/ week Hire Type 12 month contract Note : *Needs experience with Rockwell PharmaSuite* Requirement: JD: Create business process flow diagram for pharmaceutical product recipes based on the paper batch record or source documents. Gather MES Site specific requirement analysis to develop URS and FRS. Logically breakdown the recipes/Mfg. process to configure