Senior CSV & Data Integrity Lead

Inteldot; Manatí (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Inteldot is seeking an experienced Senior CSV Specialist in Puerto Rico to provide technical leadership and compliance support for computerized systems in a regulated pharmaceutical manufacturing setting.

You will ensure systems comply with cGMP, FDA, 21 CFR 11, and data integrity standards, lead validation lifecycle activities, and serve as SME across IT, QA, and manufacturing. This role also involves collaboration to maintain inspection readiness and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in science, engineering, CS, or related field.
• Significant CSV experience in regulated pharma/GMP environments.
• Strong knowledge of cGMP, FDA requirements, and data integrity.
• Proficient with 21 CFR Part 11 requirements and electronic records.

Responsibilities

• Lead CSV activities for manufacturing, labs, and quality operations.
• Develop and execute CSV plans, protocols, and qualification reports.
• Maintain Data Integrity programs and risk assessments.
• Support regulatory inspections and audits.
• Coordinate CAPA and change controls for computerized systems.
• Provide SME guidance to cross-functional teams.

Skills

CSV Expertise

Data Integrity

FDA & cGMP

21 CFR Part 11

SDLC Knowledge

Regulatory Documentation

Education

Bachelor’s degree in Science or related field

Tools

LIMS

MES

eBR Systems

Job description

Inteldot is seeking an experienced Senior CSV Specialist in Puerto Rico to provide technical leadership and compliance support for computerized systems in a regulated pharmaceutical manufacturing setting.

You will ensure systems comply with cGMP, FDA, 21 CFR 11, and data integrity standards, lead validation lifecycle activities, and serve as SME across IT, QA, and manufacturing. This role also involves collaboration to maintain inspection readiness and continuous improvement initiatives.