ZipRecruiter

Log In

1

Senior Computer System Validation Csv Jobs in Bayamon, PR

Mirus Consulting Group

Sr Engineer - 35409

Juncos, PR

$101K - $139K/yr

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

Mirus Consulting Group

Sr Engineer - 35409

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 supporting engineering ...

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 ...

MiniMed

Design Automation Engineer II

Juncos, PR

We're Looking For Sr Design Automaton Engineer. Ready to make a difference? Responsibilities may ... Knowledge of risk-based computer system validation deliverables associated with each step of the ...

New

MiniMed

Design Automation Engineer II

Juncos, PR · On-site

We're Looking For Sr Design Automaton Engineer. Ready to make a difference? Responsibilities may ... Knowledge of risk-based computer system validation deliverables associated with each step of the ...

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 ...

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

Manufacturing Engineer II

Villalba, PR · On-site

$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 ...

Mirus Consulting Group

Specialist QA - 35615

Juncos, PR · On-site

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other ...

New

Mirus Consulting Group

Engineer - 35544

Juncos, PR · On-site

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other ...

Mirus Consulting Group

Engineer - 35544

Juncos, PR

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other ...

previous pagenext page

Showing results 21-40

All JobsComputer System Validation Csv JobsSenior Computer System Validation Csv JobsSenior Computer System Validation Csv Jobs in Bayamon, PR

Senior Computer System Validation Csv information

See Bayamon, PR salary details

$31

$58

$88

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

As of Aug 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 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.
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:
What job categories do people searching Senior Computer System Validation Csv jobs in Bayamon, PR look for? The top searched job categories for Senior Computer System Validation Csv jobs in Bayamon, PR are:
Senior Computer System Validation Csv jobs near you

JT678 - QUALITY APPLICATIONS SPECIALISTS

Quality Consulting Group

Villalba, PR • On-site

Temporary

Posted 16 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:
  • Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
  • Coordinates activities with clients, programmers/developers and operating personnel, domestic and, as appropriate, global.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
  • Reports on the status of validation activities to fulfill regulatory requirements.
  • Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.

Qualifications:
  • Bachelor's degree in Engineer or Science
  • 10+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
  • Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
  • Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
  • Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability
  • Experience in equipment IQ
  • Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
  • Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
  • Preferred experience in DOE (with minitab)
  • Computer and software validation CSV
  • SOP Development
  • Change control of Medical Devices
  • 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.

Apply