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Senior Computer System Validation Csv Jobs in Bayamon, PR

FITS LLC

Project Engineer - Automation

Manati, PR · On-site

Bachelor's degree in Engineering, Computer Science, Information Systems, or related field. 5+ years ... years in CSV. * Strong knowledge of cGMP, FDA/EMA regulations, and 21 CFR Part 1 * Bilingual:

ProQualityNetwork

Senior Engineer 35449

Juncos, PR · On-site

$101K - $139K/yr

Packaging equipment and systems. * Validation lifecycle and protocol execution. * Good ... Engineering software and computer applications. Core Competencies Engineering Skills * Advanced ...

FITS LLC

Sr. Quality Engineer

Juncos, PR · On-site

$86K - $117K/yr

... CSV/OQ/PQ), equipment decommissioning, process validation, cleaning validation, and cleanroom qualification activities in GMP-regulated environments. * Strong knowledge of Quality Management Systems ...

Quality Consulting Group

JT563 - SR QUALITY ENGINEER

Juncos, PR · On-site

$86K - $117K/yr

... CSV/OQ/PQ), equipment decommissioning, process validation, cleaning validation, and cleanroom qualification activities in GMP-regulated environments. * Strong knowledge of Quality Management Systems ...

Jj

Engineering Technician (3rd Shift)

Manati, PR · On-site

... Computer Software Validations (CSV) * Serve as trainer for new and/or modified equipment. * Optimize manufacturing systems as required (e.g., modifications of programmable logic controller ...

FITS LLC

Sr. Manufacturing Engineer II

Juncos, PR · On-site

$89K - $121K/yr

... CSV) * Packaging process design, optimization, and compliance * GMP systems: HVAC, process ... and validation departments in developing requirements. * Work with project managers to complete ...

FITS LLC

Sr. Manufacturing Engineer

Juncos, PR · On-site

$89K - $121K/yr

Strong experience with equipment qualification (IQ/CSV/OQ/PQ), process validation, cleaning validation, and cleanroom qualification. * Familiarity with GMP requirements, change control, risk ...

Weil Group, Inc.

Sr. Engineer

Juncos, PR · On-site +1

$102K - $140K/yr

Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare ... Computer Literacy -Specialized equipment/process expertise -In-depth knowledge of validation ...

Deloitte

Epic Willow Senior Consultant

San Juan, PR

Conduct system testing and validation to ensure functionality and performance. Provide training and ... Bachelor's degree, preferably in Computer Science, Information Technology, Computer Engineering, or ...

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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 10, 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

Specialist Manufacturing - 35599

Mirus Consulting Group

Juncos, PR • On-site

Full-time

Posted 11 days ago

Job description

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 organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Summary
The Specialist Manufacturing is responsible for supporting and optimizing manufacturing operations within a regulated biopharmaceutical environment. This role provides technical expertise to ensure safe, compliant, and efficient manufacturing processes while driving continuous improvement initiatives. The incumbent will collaborate cross-functionally with Manufacturing, Quality, Process Development, Engineering, and Management teams to resolve process issues, improve operational performance, and maintain compliance with applicable regulatory requirements.
Key Responsibilities
  • Support daily manufacturing operations to ensure production objectives, quality standards, and compliance requirements are achieved.
  • Provide technical troubleshooting and process support for bioprocessing unit operations.
  • Lead and participate in investigations related to manufacturing deviations, non-conformances, and process events.
  • Serve as the Deviation Owner for manufacturing-related events, ensuring timely initiation, investigation, resolution, and closure of deviations in accordance with site procedures and regulatory requirements.
  • Lead and manage major and critical deviation investigations, ensuring thorough fact-finding, impact assessment, and documentation
  • Apply root cause analysis methodologies, including 5 Whys, Fishbone Diagram, Kepner-Tregoe, Six Boxes, and other structured problem-solving tools.
  • Drive continuous improvement initiatives utilizing Lean Manufacturing principles and best practices.
  • Ensure compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and site procedures.
  • Author, review, and revise technical documents, including investigations, reports, procedures, protocols, and presentations.
  • Utilize manufacturing and quality systems to monitor, document, and manage operational activities.
  • Collaborate effectively with cross-functional teams including Manufacturing, Quality, Process Development, Engineering, and site leadership.
  • Work independently with minimal supervision while effectively managing multiple priorities in a fast-paced environment.
  • Support extended work hours and overtime when required to meet business objectives.
Minimum Qualifications
  • Doctorate Degree with relevant manufacturing experience; OR
  • Master's Degree and 2 years of Manufacturing Operations experience; OR
  • Bachelor's Degree and 4 years of Manufacturing Operations experience
  • Experience supporting biopharmaceutical or biotechnology manufacturing operations.
  • Hands-on knowledge of bio-processing unit operations.
  • Experience working in highly regulated GMP environments.
  • Familiarity with Lean Manufacturing tools and continuous improvement methodologies.
  • Strong technical writing, reporting, and presentation skills.
Technical Skills
Knowledge and experience with the following systems and tools: TrackWise, Veeva, Manufacturing Execution Systems (MES), SmartSheet, Microsoft Copilot, ChatGPT, Power BI, Spotfire, CDOCS and Process Monitoring Platforms
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

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