CSV Specialist

Mirus Consulting Group; Gurabo (PR); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

mîrus Consulting Group in Humacao, Puerto Rico, seeks a CSV Specialist to manage the full validation lifecycle for pharmaceutical and biotech environments, with focus on parenteral processes and compliance with FDA, cGMP, 21 CFR Part 11, and GAMP 5.

You will develop and execute validation deliverables, support system implementations and audits, and ensure data integrity while collaborating with IT, QA, and Manufacturing.

Qualifikationen

• BS in engineering or related field required.
• Minimum 5 years in Computer System Validation in pharma/biotech.
• Strong knowledge of CSV lifecycle, 21 CFR Part 11, Annex 11, GAMP 5.
• Parenteral operations or aseptic manufacturing experience preferred.
• Excellent documentation and communication skills.

Aufgaben

• Develop, review, and execute CSV deliverables (plans, URS, IQ/OQ/PQ, validation reports).
• Ensure data integrity and regulatory compliance across systems.
• Support system implementations, migrations, and upgrades with IT/QA/Manufacturing.
• Participate in impact assessments, change control, and periodic reviews.
• Provide audit support and maintain validation documentation per GAMP 5.
• Facilitate continuous improvement and standardization of CSV practices.

Kenntnisse

CSV lifecycle

Regulatory compliance

Documentation

Team collaboration

Bilingual Spanish/English

Ausbildung

Bachelor's Degree in Engineering

Jobbeschreibung

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.