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Freelance Computer System Validation Csv Jobs in Bayamon, PR

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR

... provides computer system validation and information technology consulting services to ... The CSV Specialist will be responsible for managing and executing all activities related to ...

Techengpr

CSV C&Q Technical Lead

Carolina, PR · On-site

$120 - $180/hr

This position is ideal for a senior Computer System Validation (CSV) professional who enjoys leading technical teams, defining validation strategies, collaborating with automation and commissioning ...

FITS LLC

Sr. Quality Specialist/Engineer

Juncos, PR · On-site

$86K - $117K/yr

Execute and support Computer Systems Validation (CSV) activities. * Ensure compliance with quality systems, procedures, and applicable regulations. * Collaborate with cross-functional teams to ...

Cencora

Sr. Automation Engineer

Juncos, PR · On-site

$101K - $132K/yr

Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance. * Serve as a recognized Engineering Subject Matter Expert (SME ...

PACIV

IT / CSV Specialist

San Juan, PR · On-site

... systems, infrastructure, and validation activities within a pharmaceutical manufacturing ... Bachelor's degree in IT, Computer Science, Engineering, or a related field preferred.

Mentor Technical Group

Sr. C&Q Specialist

Juncos, PR · On-site

More than five years of experience in Equipment and Computer System Validation within pharmaceutical facilities. * Experience with digital validation solutions (e.g., ALM or equivalent systems)

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 ...

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CSV Specialist

Mirus Consulting Group

Gurabo, PR • On-site

Full-time

Re-posted 3 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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