Senior CSV Specialist - Pharma Data Integrity & Compliance

Legalpmpartners; Barceloneta (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Legal PM Partners seeks a Senior CSV Specialist to support computer system validation, IT compliance, and data integrity in a regulated pharmaceutical environment in Barceloneta, PR, US. The role involves validation documentation, risk assessment, and lifecycle compliance across manufacturing, laboratories, utilities, and packaging operations.

The candidate should bring strong CSV knowledge, data integrity expertise, and the ability to collaborate with technical and operational teams, managing

Qualifications

• Four+ years of computerized system validation experience in pharma.
• Experience supporting laboratory, sterile and non-sterile operations.
• Strong knowledge of cGMP, FDA requirements, and 21 CFR Part 11.

Responsibilities

• Plan, develop, and execute validation plans and software qualification protocols.
• Provide SME input on CSV, data integrity, and 21 CFR Part 11 for systems.
• Conduct risk assessments to determine qualification and compliance activities.
• Perform system reviews and data integrity risk assessments to identify gaps.
• Develop and maintain lifecycle documentation: requirements, specs, drawings, data maps, protocols, manuals.
• Support system modifications while preserving validated status.
• Assist software development lifecycle activities related to electronic batch records.
• Drive timely closure of incidents, investigations, CAPAs, and change controls.
• Support regulatory inspections with technical documentation and compliance input.
• Communicate risks and coordinate corrective actions with cross-functional teams.

Skills

CSV methodologies

Data integrity

Regulatory compliance

Project management

Cross-functional collaboration

Bilingual EN/ES

Education

Bachelor's degree in Science

Engineering/Computer Systems preferred

Job description

Legal PM Partners seeks a Senior CSV Specialist to support computer system validation, IT compliance, and data integrity in a regulated pharmaceutical environment in Barceloneta, PR, US. The role involves validation documentation, risk assessment, and lifecycle compliance across manufacturing, laboratories, utilities, and packaging operations.

The candidate should bring strong CSV knowledge, data integrity expertise, and the ability to collaborate with technical and operational teams, managing