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Senior Computer System Validation Csv Jobs in Connecticut

Deloitte

System Test and Validation Lead

Stamford, CT · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Stamford, CT · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Hartford, CT · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Hartford, CT · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Stamford, CT · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Deloitte

System Test and Validation Lead

Hartford, CT · On-site +1

Drive validation and compliance activities for complex GxP systems as a Senior Consultant ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Cadence Inc

Validation Engineer II

Suffield, CT · On-site

$83K - $105K/yr

Monitor system performance and lead requalification activities. * Qualify suppliers and vendors ... Requires clear communication, computer use, and occasional physical movement around facility.

Haley Ward

Survey Senior CAD Technician

Brookfield, CT · On-site

Haley Ward is looking for a Survey Senior CAD Technician who will process various surveys including ... Valid driver's license & reliable transportation A criminal background check and driving record ...

Honeywell

Automation & Validation Engineer

Guilford, CT

$85K - $106K/yr

It is a global leader in commercial fire systems and commercial security products. The primary ... The custom test framework involves robotics, computer vision, distributed computing and sensor ...

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Senior Computer System Validation Csv information

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

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

What are the key skills and qualifications needed to thrive as a senior computer system validation (CSV) professional?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges senior computer system validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is a senior computer system validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.
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Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in Connecticut as of August 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 88% Physical, 2% Hybrid, and 10% Remote job distribution.

Sr. Analyst IT Validation - Remote

Unicon Pharma Inc.

Stamford, CT • On-site

Full-time

Re-posted 12 days 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.