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Internship Computer System Validation Csv Jobs in Connecticut

Intellectt INC

Packaging Engineer

North Haven, CT · On-site

Computer System Validation (CSV) * SOP development * Change control * Custom equipment validation * Statistical Process Control (SPC) * Cross-functional collaboration * Process improvement

New

Intellectt INC

Sr. Manufacturing Engineer

North Haven, CT · On-site

$90K - $123K/yr

Computer System Validation (CSV) * Education: Bachelor's degree in Mechanical, Manufacturing, Mechatronics, Electromechanical, or Electrical/Controls Engineering. Thanks & Regards, Mahalakshmi Junior ...

New

Intellectt INC

Sr. Packaging Engineer

North Haven, CT · On-site

Computer System Validation (CSV). * Medical Device Change Control. * Custom equipment validation. * Knowledge of FDA 21 CFR Part 820, GMP, and Medical Device Quality Systems. Key Responsibilities

New

Intellectt INC

Senior Manufacturing Engineer

North Haven, CT · On-site

$90K - $123K/yr

Computer System Validation (CSV). * Automated assembly and packaging equipment experience. Thanks & Regards, Purnasree.U Recruiter Intellectt Inc Purnasree.u@intellectt.com Desk number: 7324568346 ...

New

Intellectt INC

Sr. Manufacturing Engineer

North Haven, CT · On-site

$90K - $123K/yr

Computer System Validation (CSV). * Automated assembly and packaging equipment experience. Thanks & Regards, Mahaboob M Technical Recruiter Intellectt Inc mahaboob.m@intellectt.com Direct: 732-276 ...

New

Intellectt INC

Sr. Manufacturing Engineering

North Haven, CT · On-site

$90K - $123K/yr

Preferred Skills · Design of Experiments (DOE) using Minitab. · Computer System Validation (CSV). · Custom equipment and packaging equipment validation. · Medical Device industry experience. · ...

New

Deloitte

System Test and Validation Lead

Stamford, CT · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Hartford, CT · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Hartford, CT · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Stamford, CT · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Hartford, CT · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Stamford, CT · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Lancesoft INC

Packaging Engineer II

North Haven, CT · On-site

$45 - $50/hr

Computer System Validation (CSV) / Software Validation * SOP Development * Change Control for Medical Devices Nice to Have * 1 to 3 years of Medical Device industry experience * Familiarity with FDA ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Stellantis

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

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All JobsComputer System Validation Csv JobsInternship Computer System Validation Csv JobsInternship Computer System Validation Csv Jobs in Connecticut

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 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 key skills and qualifications needed to thrive as an Internship Computer System Validation (CSV) specialist, and why are they important?

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 are some typical responsibilities for an intern in Computer System Validation (CSV), and how do they contribute to the overall validation process?

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 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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Internship Computer System Validation Csv jobs near you

Sr. Analyst IT Validation - Remote

Unicon Pharma Inc.

Stamford, CT • On-site

Full-time

Re-posted 7 hours ago

Job description

Job Title:  Sr. Analyst, IT Validation Services

Department: Information Technology

Length of Assignment: 12 Months

Work Location: Remote

Working days and Hours: Monday – Friday 35 hours (9AM-5PM)

Primary Responsibilities

  • Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls:
  • Validation Plans/Summary Reports
  • Risk Assessments
  • User Requirements
  • Specifications
  • Test Plans

Test Scripts: IQ, OQ or PQ

  • Assess and implement the most effective validation strategy for each activity.
  • Oversee test execution for cross-functional teams, including training, tracking, and reviews.
  • Build strong relationships with business counterparts to understand processes and requirements, ensuring delivery of compliant computer system solutions.
  • Work effectively with IT colleagues to ensure compliance with validation processes and proper documentation.
  • Collaborate with Information System Quality Assurance (ISQA) to ensure compliance on all projects, procedures and audits related to Information Technology.

Education and Experience Requirements

  • BS/Equivalent Training/Certification and minimum of 5 years of relevant experience in computer systems validation, change management and systems development life cycle methodologies.

Necessary Knowledge, Skills, and Abilities

  • Expertise in Computer System Validation (CSV), Systems Development Life Cycle (SDLC) methodologies and CSV regulations, standards, and best practices
  • Working knowledge of Computer Software Assurance (CSA) guidance and its applicability.
  • Excellent written and verbal communication skills with a focus on Good Documentation Practices (GDP).

Technical knowledge of the following computer systems and software (at a minimum):

  • MS software packages such as Outlook, Word, Excel, PowerPoint and MS Project
  • SAP, LIMS, or other Manufacturing, Distribution and Laboratory systems
  • Veeva Vault
  • ServiceNow
  • Robust knowledge and understanding of pharmaceutical manufacturing, packaging, operations, quality, and supply chain processes and related systems.
  • Working knowledge of project management principles, and ability to operate under tight timelines, within budget and to specified quality and compliance goals.
  • Solid relationship and conflict management skills, and ability to navigate complex, fast-moving, business environments in a self-directed manner.

Supervisory Responsibilities (if applicable):

  • There are no supervisory responsibilities expected in this position.