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From Home Computer System Validation Jobs in Texas

Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.

Graphcore's teams are drawn from diverse backgrounds and bring a broad range of skills and perspectives. Job Summary We are seeking a Staff System Validation Engineer to design and implement ...

Graphcore's teams are drawn from diverse backgrounds and bring a broad range of skills and perspectives. Job Summary We are seeking a Staff System Validation Engineer to design and implement ...

Description Ownership of SerDes system bring-up, validation and debug. This will involve a SerDes ... Hands-on experience with AMS IC development from definition to high-volume production including ...

Description Ownership of SerDes system bring-up, validation and debug. This will involve a SerDes ... Hands-on experience with AMS IC development from definition to high-volume production including ...

Exposure to system validation and CSV (Computer System Validation) processes * Familiarity with ISA-95 integration concepts * Strong communication skills and ability to work in cross-functional teams

Exposure to system validation and CSV (Computer System Validation) processes * Familiarity with ISA-95 integration concepts * Strong communication skills and ability to work in cross-functional teams

Monitor and evaluate system performance to ensure continued validated state Required Qualifications: * Bachelor's degree in Engineering, Computer Science, or related technical field * Minimum 5 years ...

FEDITC develops mission critical national security systems throughout the world directly supporting ... or removed from RRAD's asset management lists and databases. * Must complete all required ...

FEDITC develops mission critical national security systems throughout the world directly supporting ... or removed from RRAD's asset management lists and databases. * Must complete all required ...

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From Home Computer System Validation information

What is the difference between From Home Computer System Validation vs From Home Quality Assurance Specialist?

AspectFrom Home Computer System ValidationFrom Home Quality Assurance Specialist
CertificationsGxP validation, 21 CFR Part 11ISO 9001, QA certifications
Work EnvironmentPrimarily remote, focused on system testing and validationRemote or onsite, focused on process audits and compliance
Industry UsagePharmaceutical, biotech, healthcareManufacturing, software, healthcare
Job FocusEnsuring computer systems meet regulatory standardsEnsuring overall quality processes and compliance

From Home Computer System Validation primarily involves verifying that computer systems meet regulatory standards, especially in healthcare and biotech industries. In contrast, From Home Quality Assurance Specialist focuses on broader quality processes and compliance across various industries. Both roles may be remote and require similar certifications, but their core responsibilities differ in scope and focus.

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Computer System Validation-Pharmaceutical

PharmEng Technology

Fort Worth, TX

Other

Posted 24 days ago


Job description

Title: Computer Validation Specialist-PQM Location: Fort Worth, TX Company: PharmEng Technology Inc. PharmEng Technology is a full service consulting firm that serves the pharmaceutical, medical devices and biotechnology industries in North America and internationally. Since 1997, the company has provided industry recognized consulting services assisting clients in the rapid commercialization of new product from drug discovery, strategic planning to process scale up.

PharmEng has immediate opening for candidates with experience in Process Validation Engineer. Essential Functions and Responsibilities Proficient in Validation and Qualification aspects of systems. If required, creates and documents Validation Plan, Quality Plan, IQ Report, OQ Report, and Validation Summary Reports.

Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements Conduct Quality reviews to evaluate if processes and deliverables fulfill the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement Follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course Contribute to business decisions in the decisions in the definition and assessment of IT requirements Support the development and delivery of training in quality matters Drive and facilitate create of relevant of system SOPs. Prepare and follow internal authority inspections. Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality deliverables.

Coordination documentation, testing and change management activities to ensure compliance with business and regulatory needs Develop PQM resources for projects and services and monitor their performance to ensure adherence with agreed quality systems. Forecast demand and plan for IT PQM related to projects, provide task estimating and ICE roadmap to PMs, monitor and manage project risk and compliance Ownership IT CAPA and CCR Process for the responsible functional areas. Minimum Qualifications: Bachelor's of Science and a minimum of 5 years experience in IT in pharmaceutical industry with expert knowledge of current regulations Ability to interact with all levels of the organization Influence and leadership capability, and credibility within the business Strong organization skills Strong written and verbal communication skills Excellent written and spoken English Thank you for your interest in our organization.

However, only those selected will be contacted for an interview.