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Senior Computer System Validation Csv Jobs in Bayamon, PR

Techengpr

CSV C&Q Technical Lead

Carolina, PR · On-site

$150 - $200/hr

This position is ideal for a senior Computer System Validation (CSV) professional who enjoys leading technical teams, defining validation strategies, collaborating with automation and commissioning ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

$60 - $80/hr

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

FITS LLC

Sr. Quality Specialist/Engineer

Juncos, PR · On-site

$80 - $100/hr

Execute and support Computer Systems Validation (CSV) activities. * Ensure compliance with quality systems, procedures, and applicable regulations. * Collaborate with cross-functional teams to ...

FITS LLC

Sr. Quality Specialist/Engineer

Juncos, PR · On-site

$86K - $116K/yr

Execute and support Computer Systems Validation (CSV) activities. * Ensure compliance with quality systems, procedures, and applicable regulations. * Collaborate with cross-functional teams to ...

Cencora

Sr. Automation Engineer

Juncos, PR · On-site

$101K - $132K/yr

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Serve as a recognized Engineering Subject Matter Expert (SME ...

Veg Group

Specialist QA (5:00 pm - 5:30 am)

Juncos, PR · On-site

$80 - $100/hr

Alert senior management of quality, compliance, supply, and safety risks. * Provide support and ... Experience in computer systems validation (CSV) or computer systems quality assurance, including ...

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Senior Computer System Validation Csv information

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How much do senior computer system validation csv jobs pay per hour?

As of Sep 7, 2026, the average hourly pay for senior computer system validation csv in Bayamon, PR is $58.34, according to ZipRecruiter salary data. Most workers in this role earn between $46.54 and $66.25 per hour, depending on experience, location, and employer.

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.

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 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 most commonly searched types of Computer System Validation Csv jobs in Bayamon, PR?

The most popular types of Computer System Validation Csv jobs in Bayamon, PR are:

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Senior Computer System Validation Csv jobs near you

CSV C&Q Technical Lead

Technical and Engineering Consulting

Carolina, PR • On-site

Full-time

Re-posted 9 days ago

Job description

About the Opportunity

Technical & Engineering Consulting LLC is seeking an experienced Automation / CSV C&Q Technical Lead to support one of the most important pharmaceutical capital projects in Puerto Rico.

This position is ideal for a senior Computer System Validation (CSV) professional who enjoys leading technical teams, defining validation strategies, collaborating with automation and commissioning teams, and ensuring regulatory compliance throughout the project lifecycle.

The selected consultant will serve as the primary CSV technical lead, supporting computerized systems and automation associated with manufacturing process equipment from design through commissioning, qualification, startup, and final handover.

What You'll Do

As the Automation / CSV C&Q Technical Lead, you will:

  • Lead the Computer System Validation (CSV) strategy for the project.
  • Define validation requirements and technical direction throughout the project lifecycle.
  • Partner with Process Engineering to ensure automation solutions meet business requirements.
  • Provide technical leadership during software development and testing activities.
  • Collaborate closely with Design Verification, CQV, Automation Engineering, Operations, Quality, and external vendors.
  • Develop and review:
    • Validation Plans
    • User Requirements
    • Functional Specifications
    • Design Specifications
    • Requirements Traceability Matrices (RTM)
    • Test Scripts
    • Validation Summary Reports
  • Lead execution of IQ, OQ, and PQ protocols for automation and computerized systems.
  • Support FAT and SAT activities.
  • Manage deviations, investigations, change controls, and validation documentation.
  • Develop CSV training plans and training matrices.
  • Monitor CSV milestones, schedules, and project deliverables.
  • Ensure compliance with GAMP 5, Data Integrity (ALCOA+), cGMP, and company quality procedures.
  • Support system turnover to Manufacturing and Operations.
Required Qualifications
  • Bachelor's Degree in Automation, Controls, Chemical Engineering, Electrical Engineering, Computer Science, or related discipline.
  • Significant experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, or other FDA-regulated environments.
  • Experience leading CSV activities on capital projects.
  • Strong understanding of:
    • GAMP 5
    • 21 CFR Part 11
    • Data Integrity (ALCOA+)
    • cGMP requirements
  • Hands-on experience developing and executing:
    • IQ/OQ/PQ
    • Validation Plans
    • RTMs
    • Test Scripts
    • Validation Reports
  • Experience supporting automation platforms and computerized manufacturing systems.
  • Experience with technical change management and deviation management.
  • Excellent technical writing and documentation skills.
  • Strong communication and leadership abilities.
Preferred Qualifications

Experience with one or more of the following is highly desirable:

  • Large pharmaceutical capital projects
  • Automation Lead or CSV Technical Lead roles
  • Manufacturing Execution Systems (MES)
  • Batch reporting systems
  • Data Historians
  • Alarm Management
  • FAT/SAT execution
  • Lilly systems and quality procedures
  • Regulatory inspections and FDA audits
What We're Looking For

The ideal candidate is:

  • A technical leader who can influence cross-functional teams
  • Highly organized and detail-oriented
  • Comfortable working in a fast-paced capital project environment
  • Experienced coordinating with engineering firms, automation integrators, contractors, and quality organizations
  • Passionate about delivering compliant, high-quality validation documentation
Why Join Technical & Engineering Consulting?

At Technical & Engineering Consulting LLC, you'll have the opportunity to contribute to some of Puerto Rico's largest pharmaceutical manufacturing projects while working alongside industry-leading engineering and validation professionals.

We value technical excellence, integrity, collaboration, and long-term professional relationships.

Apply