Senior CSV & Data Integrity Specialist

Mirus Consulting Group; Manatí (PR); On-site; USD 100,000 - 160,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico seeks a Senior CSV Specialist responsible for IT Computerized Systems validation, data integrity and regulatory compliance across Sterile, Non-Sterile, Utilities, Facilities and QC/QA areas.

You will design and execute validation protocols, support 21 CFR Part 11, and lead data integrity assessments, CAPAs and change controls to keep systems compliant.

Qualifications

• Bachelor’s Degree in Science (Computer Systems or Engineering preferred).
• Thorough knowledge of cGMP, FDA and Data Integrity regulations.
• Experience with computerized system validation methodologies, 21 CFR Part 11, and Data Integrity regulations.
• Minimum of four (4) years of CSV and data integrity experience in pharma manufacturing.
• Experience supporting laboratory, sterile and non-sterile operations.
• Strong project management skills and regulatory liaison experience.
• Fluency in Spanish and English.

Responsibilities

• Assures IT Compliance commitments are planned, monitored and completed per regulations.
• Serves as Site IT SME for IT Compliance issues including Data Integrity and 21 CFR Part 11.
• Develops and sustains an efficient CSV program aligned with regulatory requirements.
• Ensures periodic reviews for computerized systems are completed as planned.
• Performs data integrity assessments and mitigates risks prior to system release.
• Leads detection and remediation of Data Integrity deficiencies and CAPAs.

Skills

CSV compliance

cGMP knowledge

Regulatory knowledge

Project management

Bilingual EN/ES

Education

Bachelor’s Degree in Science

Minimum 4 years CSV experience

Job description

mîrus Consulting Group in Humacao, Puerto Rico seeks a Senior CSV Specialist responsible for IT Computerized Systems validation, data integrity and regulatory compliance across Sterile, Non-Sterile, Utilities, Facilities and QC/QA areas.

You will design and execute validation protocols, support 21 CFR Part 11, and lead data integrity assessments, CAPAs and change controls to keep systems compliant.