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Senior Computer System Validation Csv Jobs in Puerto Rico

Mirus Consulting Group

Sr Engineer - 35630

Juncos, PR · On-site

$125 - $150/hr

... computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include ...

Mirus Consulting Group

Sr Engineer - 35630

Juncos, PR · On-site

$101K - $139K/yr

... provides computer system validation and information technology consulting services to ... Position Summary The Senior Engineer is responsible for leading and executing commissioning ...

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 ...

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

$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 ...

Pinnaql

CQV Specialist Utilities

Juncos, 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 ...

Veg Group

CQV Specialist Utilities

Juncos, PR · On-site

$100 - $125/hr

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

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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 are popular job titles related to Senior Computer System Validation Csv jobs in Puerto Rico?

For Senior Computer System Validation Csv jobs in Puerto Rico, the most frequently searched job titles are:

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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

JT587 - MANUFACTURING ENGINEER II

Quality Consulting Group

Villalba, PR • On-site

$70K - $91K/yr

Temporary

Re-posted 13 days ago

Job description

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
  • Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
  • Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
  • Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
  • Adapts machine or equipment design to factory and production conditions.
  • May incorporate inspection and test requirements into the production plan.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.

Qualifications:
  • Bachelor's degree in Engineering
  • 3+ years of relevant experience.
  • Process Development and documentation
  • Equipment validation
  • SOP Development
  • Special Build Documentation and Line Support
  • Experience in equipment IQ |Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
  • Process Validation Lifecycle ( from process characterization, operational qualification to performance qualification)
  • SOP Development | Special Build Documentation and Line Support
  • Computer and software validation CSV
  • Change control of Medical Devices
  • MES system
  • Experience in injection molding processes
  • Shift: 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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