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Biotech Csv Jobs in Puerto Rico (NOW HIRING)

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

Minimum of 5 years of hands-on experience in Computer System Validation within the pharmaceutical or biotechnology industry. * Strong knowledge of CSV lifecycle methodology, 21 CFR Part 11, Annex 11 ...

Validation & Engineering Group, Inc

PR

... Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory ... Develop/execute CSV deliverables for EVRS modules that manage recipes (formulas), master batch ...

JC Automation Corp

PR · On-site

$25 - $35/hr

... CSV) activities and documentation. * Familiarity with OSI PI historian or equivalent data contextualization platforms. * Prior experience in a pharmaceutical, biotech, or FDA-regulated manufacturing ...

LEGAL PROJECT MANAGEMENT PARTNERS LLC

PR · On-site

... Validation (CSV), or related technologies is preferred. • Strong project planning and ... within pharmaceutical, biotech, medical device, or regulated manufacturing environments. • ...

LEGAL PROJECT MANAGEMENT PARTNERS LLC

PR · On-site

... Validation (CSV), or related technologies is preferred. • Strong project planning and ... within pharmaceutical, biotech, medical device, or regulated manufacturing environments. • ...

LEGAL PROJECT MANAGEMENT PARTNERS LLC

PR · On-site

... Validation (CSV), or related technologies is preferred. • Strong project planning and ... within pharmaceutical, biotech, medical device, or regulated manufacturing environments. • ...

Mirus Consulting Group

Sr. Engineer

Juncos, PR · On-site

$101K - $139K/yr

The company specializes in Computer System Validation (CSV) and Information Technology consulting ... biotech/medical devices) • Strong hands-on experience in process validation and packaging systems ...

Validation & Engineering Group, Inc

PR

... Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory ... validation (CSV) or computer systems quality assurance, including consulting level technical ...

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Biotech Csv information

What are some common challenges faced by Biotech CSV professionals when ensuring compliance with regulatory standards?

Biotech CSV (Computer System Validation) professionals often encounter challenges such as keeping pace with evolving regulatory requirements and ensuring that validation documentation is both thorough and audit-ready. Navigating the complexity of integrating new software or technologies into existing validated systems can also be demanding. Effective communication with cross-functional teams—such as quality assurance, IT, and laboratory staff—is crucial to address gaps and maintain compliance. Staying organized and proactive in risk management helps CSV professionals overcome these hurdles and support successful regulatory inspections.

What are Biotech CSV professionals?

Biotech CSV (Computer System Validation) professionals are experts who ensure that computerized systems used in biotechnology and pharmaceutical industries meet regulatory requirements and function as intended. They are responsible for planning, executing, and documenting validation activities to ensure data integrity, product quality, and compliance with standards such as FDA 21 CFR Part 11. Their role is crucial in maintaining reliable and compliant technology solutions throughout the product lifecycle, helping companies avoid costly errors and regulatory penalties.

What are the key skills and qualifications needed to thrive as a Biotech CSV (Computer System Validation) Specialist, and why are they important?

To thrive as a Biotech CSV Specialist, you need a solid understanding of computer system validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, quality management systems (QMS), and relevant software like TrackWise or MasterControl is crucial. Strong analytical thinking, attention to detail, and effective communication are standout soft skills in this role. These skills and qualities ensure validated systems meet regulatory standards, minimize compliance risks, and support reliable biotech research and manufacturing processes.
What are popular job titles related to Biotech Csv jobs in Puerto Rico? For Biotech Csv jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Biotech Csv jobs in Puerto Rico look for? The top searched job categories for Biotech Csv jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Biotech Csv jobs? Cities in Puerto Rico with the most Biotech Csv job openings:
Biotech Csv jobs near you
Infographic showing various Biotech Csv job openings in Puerto Rico as of July 2026, with employment types broken down into 87% Full Time, 4% Part Time, 1% Temporary, and 8% Contract. Highlights an 82% Physical, 3% Hybrid, and 15% Remote job distribution.

CSV Specialist

Mirus Consulting Group

Gurabo, PR • On-site

Full-time

Posted 10 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 CSV Specialist will be responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across manufacturing and quality systems, with a strong focus on parenteral processes and regulated environments.
Key Responsibilities:
  • Develop, review, and execute CSV deliverables including Validation Plans, Risk Assessments, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports.
  • Ensure that computerized systems meet data integrity and regulatory compliance requirements.
  • Support system implementations, migrations, and upgrades, collaborating closely with IT, QA, and Manufacturing teams.
  • Participate in impact assessments, change control activities, and periodic system reviews.
  • Provide technical and compliance support during internal and external audits.
  • Maintain validation documentation in alignment with company quality systems and GAMP 5 guidance.
  • Support troubleshooting, deviation resolution, and CAPA implementation related to validated systems.
  • Promote continuous improvement and standardization of CSV practices across site operations.

Qualifications & Requirements:
  • Bachelor's Degree in engineering
  • Minimum of 5 years of hands-on experience in Computer System Validation within the pharmaceutical or biotechnology industry.
  • Strong knowledge of CSV lifecycle methodology, 21 CFR Part 11, Annex 11, and GAMP 5.
  • Experience with parenteral operations or aseptic manufacturing environments preferred.
  • Excellent documentation, communication, and teamwork skills.
  • Fully bilingual (Spanish/English) preferred.
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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