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Senior Computer System Validation Csv Jobs in Puerto Rico

Validation & Engineering Group, Inc

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Experience with non-critical utilities and system validation activities is considered a strong ...

Mirus Consulting Group

Sr Engineer - 35600

Juncos, PR · On-site

$101K - $139K/yr

... provides computer system validation and information technology consulting services to ... Position Summary We are seeking a highly motivated Senior Engineer to provide technical expertise ...

Mirus Consulting Group

Sr Engineer - 35600

Juncos, PR · On-site

$101K - $139K/yr

... provides computer system validation and information technology consulting services to ... Position Summary We are seeking a highly motivated Senior Engineer to provide technical expertise ...

Validation & Engineering Group, Inc

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... Validate and qualify equipment, facilities, utilities, cleanrooms, and other systems that may ...

New

FITS LLC

Senior Manufacturing Engineer

Juncos, PR · On-site

$89K - $121K/yr

Computer Systems validations The Personality Part: * If you have excellent communication skills and aren't afraid to ask for help when you need it (in addition to your excellent Maintenance skills ...

Validation & Engineering Group, Inc

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services ... senior) with strong expertise in utilities and facilities systems to support commissioning ...

Three Point Solutions

PR · On-site

$80 - $110/hr

Senior Engineering/ IT Program Manager Client: Medical Device Manufacturing Company Duration: 12 ... Systems * Lead MES and automation initiatives * Oversee CSV, IQ/OQ/PQ validation * Ensure FDA, ISO ...

Weil Group, Inc

Manufacturing Engineer II

Villalba, PR · On-site

$70K - $91K/yr

Computer and software validation CSV SOP Development Change control of Medical Devices MES system Experience in injection molding processes Designs manufacturing processes, procedures and production ...

Weil Group, Inc.

Manufacturing Engineer II

Villalba, PR · On-site +1

$70K - $91K/yr

Computer and software validation CSV SOP Development Change control of Medical Devices MES system Experience in injection molding processes Designs manufacturing processes, procedures and production ...

Weil Group, Inc.

Manufacturing Engineer II

Villalba, PR · On-site +1

$70K - $91K/yr

Computer and software validation CSV SOP Development Change control of Medical Devices MES system Education Required: Bachelor's degree required in Engineering Years' Experience Required: Minimum of ...

Weil Group, Inc

PR

... and computer systems. 11. Works with IT Management and the site's Management in the assessment, recommendation, validation, implementation and administration of the Computerized Systems. Leads ...

Weil Group, Inc

Manufacturing Engineer II

Villalba, PR

$70K - $91K/yr

Computer and software validation CSV SOP Development Change control of Medical Devices MES system Education Required: Bachelor's degree required in Engineering Years' Experience Required: Minimum of ...

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Senior Computer System Validation Csv information

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 Puerto Rico?

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

What job categories do people searching Senior Computer System Validation Csv jobs in Puerto Rico look for?

The top searched job categories for Senior Computer System Validation Csv jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Senior Computer System Validation Csv jobs?

Cities in Puerto Rico with the most Senior Computer System Validation Csv job openings:

Senior Computer System Validation Csv jobs near you

CQV Specialist Utilities

Validation & Engineering Group, Inc

PR • On-site

Full-time

Posted 20 days ago

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • CQV Specialist Utilities

Description:

Supports commissioning, qualification, validation, and maintenance programs in GMP-regulated facilities. Performs activities in accordance with regulatory requirements and industry best practices while working effectively in a multidisciplinary project environment. Experience with non-critical utilities and system validation activities is considered a strong asset.

Responsibilities:

  • Support commissioning, qualification, validation, and maintenance programs.
  • Work in accordance with regulatory requirements and industry best practices.
  • Work effectively in a multidisciplinary project environment.

Qualifications:

  • Hands-on experience in commissioning, qualification, validation, and/or maintenance programs.
  • Familiarity with regulatory requirements and industry best practices.
  • Ability to work effectively in a multidisciplinary project environment.
  • Experience with non-critical utilities and system validation activities is highly appreciated and considered a strong asset for these roles.
  • Must be fully bilingual (English / Spanish) with excellent oral skills.
  • Must be proficient using MS Windows and Microsoft Office applications.
  • Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
  • Strong experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
  • Technical Writing skills and investigations processes.
  • Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.