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Senior Computer System Validation Csv Jobs in Puerto Rico

JC Automation Corp

PR · On-site

$18/hr

... computer system validation (CSV) activities, under the guidance of senior team members. * Multi-Site Adaptability: Demonstrate flexibility and professionalism by working across diverse project sites ...

JC Automation Corp

PR · On-site

$18/hr

... computer system validation (CSV) activities, under the guidance of senior team members. * Multi-Site Adaptability: Demonstrate flexibility and professionalism by working across diverse project sites ...

Mirus Consulting Group

MES Project Manager

Manati, PR · On-site

$83K - $98K/yr

The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States.

Inteldot

MES Specialist

San Juan, PR · On-site

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

Mirus Consulting Group

MES Project Manager

Manati, PR

$83K - $98K/yr

The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States.

PACIV

Senior Automation Technician

San Juan, PR · On-site

$102K - $133K/yr

Bachelor's degree in Engineering (Electrical, Computer, Mechanical) or equivalent experience ... Experience supporting automation system validation (CSV) and documentation tools such as Kneat.

FITS LLC

Sr. Manufacturing Engineer- 149

Juncos, PR · On-site

$89K - $121K/yr

Performing and applying knowledge of Computer System Validation (CSV) * Executing documentation changes The Personality Part: * Our Next Piece is someone who treats everyone they meet like family ...

Mirus Consulting Group

Sr. Engineer

Juncos, PR

$101K - $139K/yr

The company specializes in Computer System Validation (CSV) and Information Technology consulting ... Position Overview The Senior Engineer will provide technical leadership and hands-on engineering ...

Mirus Consulting Group

Sr. Engineer

Juncos, PR · On-site

$101K - $139K/yr

The company specializes in Computer System Validation (CSV) and Information Technology consulting ... Position Overview The Senior Engineer will provide technical leadership and hands-on engineering ...

FITS LLC

Sr. Quality Specialist/Engineer

Juncos, PR · On-site

$86K - $117K/yr

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

Mirus Consulting Group

Project Manager

Manati, PR · On-site

The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States.

PACIV

Automation Engineer

San Juan, PR · On-site

Experience with computer systems validation (CSV) in regulated/GMP environments. Desired Soft Skills: * Strong problem-solving, communication, leadership, and teamwork skills. * Ability to manage ...

JC Automation Corp

PR · On-site

$25 - $35/hr

Exposure to Computer System Validation (CSV) activities and documentation. * Familiarity with OSI PI historian or equivalent data contextualization platforms. * Prior experience in a pharmaceutical ...

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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, and why are they important?

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

Dynamic Program - Automation & PLC Training

JC Automation Corp

PR • On-site

$18/hr

Full-time

Posted 26 days ago

Job description

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

Dynamic is JCA's multi-week professional development program designed to provide comprehensive, hands-on training to the next generation of Automation and PLC professionals. Built specifically for recent graduates, this program bridges the gap between academic knowledge and real-world industry application — combining an intensive 3-week training bootcamp with 1.5 years of project-based work experience across diverse client locations.

Participants will work alongside experienced engineers and automation specialists, gaining direct exposure to live projects in regulated pharmaceutical and industrial environments. With a strong emphasis on PLC programming, FDA compliance, GMP principles, and safety protocols, Dynamic equips emerging professionals with the technical foundation and professional confidence to build a meaningful career in industrial automation.

This is a full-time position. No prior work experience is required — Dynamic is designed precisely for those ready to launch their careers with purpose.

RESPONSIBILITIES

  • Intensive Training Participation: Complete an intensive 3-week training program covering critical topics in PLC systems, automation fundamentals, regulatory compliance, GMP principles, and safety protocols in industrial environments.
  • Project-Based Field Work: Collaborate with experienced engineers and automation specialists on real projects across multiple client locations, gaining direct hands-on experience in automation and computerized system environments.
  • Regulatory Compliance: Ensure adherence to FDA regulations, applicable safety standards, and industry compliance requirements throughout all assigned project activities.
  • Engineering Project Support: Assist in the management and execution of assigned engineering projects, including automation implementations and computer system validation (CSV) activities, under the guidance of senior team members.
  • Multi-Site Adaptability: Demonstrate flexibility and professionalism by working across diverse project sites and adapting to varying client environments, schedules, and technical requirements throughout the 1.5-year program commitment.

WHAT YOU'LL GAIN

  • Hands-on experience with real automation and PLC projects from day one.
  • Direct mentorship and guidance from experienced engineers and industry specialists.
  • Exposure to FDA-regulated pharmaceutical and industrial manufacturing environments.
  • Development of a strong technical foundation in PLC programming, GMP, safety, and compliance.
  • Professional growth support — including career orientation, goal-setting, and advancement guidance throughout the program.
  • A clear pathway toward a full-time professional role in industrial automation upon program completion.

REQUIREMENTS & QUALIFICATIONS

Required

  • Associate's degree in Science, Instrumentation, Control Systems, Electronics, or a related technical discipline.
  • No prior work experience required — this program is designed specifically for recent graduates.
  • Strong problem-solving skills and a genuine eagerness to learn in a technical environment.
  • Excellent communication and teamwork skills.
  • Flexibility and willingness to relocate and work across multiple project sites during the 1.5-year program commitment.
  • Bilingual in English and Spanish (oral and written).

Preferred

  • Basic familiarity with PLC concepts, ladder logic, or control systems through coursework or academic projects.
  • Exposure to industrial automation, instrumentation, or process control in an academic or lab setting.
  • Knowledge of GMP principles or regulatory frameworks through coursework.

SKILLS

Technical Skills

  • PLC systems — foundational programming and troubleshooting (developed through program)
  • Automation and control system fundamentals
  • FDA regulations and compliance requirements — awareness level
  • Good Manufacturing Practices (GMP) — principles and application
  • Safety protocols and best practices in industrial automation environments
  • Computer System Validation (CSV) — introductory support level
  • Microsoft Office Suite — Word, Excel, PowerPoint, Outlook

Soft Skills

  • Eager to learn and grow in a technically demanding, fast-paced environment
  • Strong critical thinking and analytical problem-solving approach
  • Collaborative team player who communicates clearly and professionally
  • Adaptable and open to working across different sites, teams, and project types
  • Reliable, accountable, and committed to the full program duration
  • Self-motivated with a proactive attitude toward professional development