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Internship Computer System Validation Csv Jobs in Connecticut

Develops and executes validation protocols based on system requirements and approved procedures and ... computer science) and 2+ years of relevant experience. * Previous experience in supporting ...

Develops and executes validation protocols based on system requirements and approved procedures and ... computer science) and 2+ years of relevant experience. * Previous experience in supporting ...

Analysis and design of building/facility structural systems/components in steel, concrete, masonry ... Coordination with other Engineers, Engineering interns, CAD Technicians and other disciplines will ...

Structural Engineer

New Britain, CT · On-site

$120 - $180/hr

Analysis and design of building/facility structural systems/components in steel, concrete, masonry ... Coordination with other Engineers, Engineering interns, CAD Technicians and other disciplines will ...

Act as Design Lead and/or vet new WMS implementations or where KN WMS is in scope, in accordance with KN Standards such as Computer System Validation where appropriate. * Drive Partner Management ...

AVS Bio Senior QA Scientist

Storrs, CT · On-site

$76.50 - $93.50/hr

Proven experience designing and executing validation protocols (process, method, equipment, CSV/computer systems). * Demonstrated experience leading or supporting regulatory inspections (FDA, EMA ...

... validation and reconciliation tasks for strategy metrics and features ... Help create and update technical documentation for MCPs, related systems, and user guides.

Showing results 21-40

Internship Computer System Validation Csv information

What is an internship in computer system validation (CSV)?

An Internship in Computer System Validation (CSV) is a temporary position, typically for students or recent graduates, that provides hands-on experience in ensuring that computer systems used in regulated industries (like pharmaceuticals or healthcare) meet required standards and regulations. Interns assist with validating software and hardware, documenting processes, and ensuring compliance with industry guidelines such as FDA 21 CFR Part 11 or EU Annex 11. This role helps interns understand the lifecycle of computer systems in a regulated environment and prepares them for careers in quality assurance, compliance, or IT within highly regulated sectors.

What are the typical responsibilities of an intern in computer system validation (CSV)?

As a Computer System Validation (CSV) intern, you can expect to assist with tasks such as reviewing and drafting validation documentation, executing test scripts, and collecting evidence to ensure compliance with regulatory requirements. You may also support the maintenance of validation records and participate in team meetings to discuss project progress or findings. These responsibilities are crucial in ensuring that computer systems used in regulated industries, like pharmaceuticals or healthcare, function as intended and meet quality standards. Working closely with senior validation specialists, you'll gain hands-on experience with industry guidelines and learn how cross-functional teams collaborate to achieve compliance.

What are the key skills and qualifications needed for an internship in computer system validation (CSV)?

To thrive as an Internship Computer System Validation CSV specialist, you need foundational knowledge in computer science, life sciences, or engineering, along with an understanding of regulatory standards like GxP or FDA 21 CFR Part 11. Familiarity with validation documentation, software testing tools, and quality management systems is typically required. Attention to detail, analytical thinking, and effective communication are crucial soft skills for interpreting requirements and collaborating with cross-functional teams. These skills ensure compliance, data integrity, and the successful validation of computerized systems in regulated environments.

What is the difference between Internship Computer System Validation Csv vs Computer System Validation Specialist?

AspectInternship Computer System Validation CsvComputer System Validation Specialist
CredentialsTypically pursuing or recent graduate, basic understanding of validationRelevant certifications (e.g., GAMP, ISPE), experience preferred
Work EnvironmentInternship setting, supervised, entry-level tasksFull-time role, independent responsibilities in regulated industries
Industry UsageUsed in pharmaceutical, biotech, and medical device companies for trainingUsed for maintaining compliance, validating systems in regulated environments

In summary, the Internship Computer System Validation Csv is an entry-level position focused on learning and supporting validation tasks, while the Computer System Validation Specialist is a more experienced role responsible for ensuring system compliance and validation in regulated industries.

What are the most commonly searched types of Computer System Validation Csv jobs in Connecticut?

The most popular types of Computer System Validation Csv jobs in Connecticut are:

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The top searched job categories for Internship Computer System Validation Csv jobs in Connecticut are:

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Cities in Connecticut with the most Internship Computer System Validation Csv job openings:

Contractor

Re-posted 3 days ago


Job description

Company Description
  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description

Responsibilities:

  • As a Validation Engineer within the Mold & Capital Tooling Organization, you'll play a pivotal role on a global enterprise team, collaborating with various sites around the world. In this role, you'll facilitate or perform critical validation & qualification activities, ensuring the seamless release of high-quality injection molded components that drive our mission forward.
  • Ensure proper qualification and validation of suppliers and their processes, ensuring supplier meets the requirements for producing high-quality, reliable products.
  • Developing and executing validation plans, conducting audits, and managing the overall PPAP process to ensure compliance with ISO 13485/ Medical standards.
  • Write, review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures, standard calibration methods, standard test methods, specifications CAPAs and exception reports.
  • Strong documentation skills - Accurately recording and managing validation processes in compliance with internal SOPs and external regulations.
  • Review test results and measurements to identify discrepancies.
    SPC (Statistical Process Control).
  • Knowledge on ISO 13485, FDA GMP, ISO 14971, FDA CFR 820.
  • Clean Room experience and medical prod mfg exp (added advantage).
  • Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.

Requirements:

  • Bachelor's degree with a minimum of 5-7 years of experience in a regulated environment, OR an advanced degree with a minimum of 3 years of experience.
  • Minimum of 5 years of professional experience in a relevant field.
  • Experience with Agile PLM and SAP or BPCS ERP systems.
  • Experience with CAD model with use of Solid works or AutoCAD.
  • Experience with NPI and design transfers deliverables for injection moulded components.
  • Experience within highly regulated industry.
  • Hands on experience within production and enterprise environment.
Additional Information

All your information will be kept confidential according to EEO guidelines.


Katalyst Healthcares & Life Sciences logo

About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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