Senior CSV Specialist | Pharmaceutical in MANATI at LEGAL PROJECT MANAGEMENT PARTNERS LLC

Location: North Area, Puerto Rico

Industry: Pharmaceutical

POSITION SUMMARY

Legal PM Partners is seeking an experienced Senior CSV Specialist to support computer system validation (CSV), IT compliance, and data integrity within a regulated pharmaceutical environment.

This professional will support computerized systems used in manufacturing, laboratories, utilities, facilities, inspection, and packaging operations. The role involves developing and executing validation documentation, assessing system risks, and helping ensure that computerized systems remain compliant, validated, and suitable for their intended use throughout their lifecycle.

The ideal candidate will bring strong technical knowledge of CSV methodologies, data integrity, and regulatory requirements, along with the ability to collaborate with technical and operational teams and manage validation activities independently.

MAIN RESPONSIBILITIES

• Plan, develop, and execute computer validation plans and software/system qualification protocols in accordance with applicable regulations and approved procedures.

• Provide subject matter expertise in CSV, data integrity, and 21 CFR Part 11 for laboratory, manufacturing, and packaging systems.

• Perform validation needs assessments to determine appropriate qualification and compliance activities for new and existing computerized systems.

• Conduct periodic system reviews and data integrity risk assessments to identify compliance gaps and recommend mitigation measures.

• Develop and maintain system lifecycle documentation, including requirements, specifications, drawings, data mappings, qualification protocols, and system manuals.

• Support the implementation and validation of approved system modifications while maintaining the validated status of computerized systems.

• Support software development lifecycle activities related to electronic batch records.

• Drive the timely completion of computerized-system incidents, investigations, audit observations, corrective and preventive actions (CAPAs), and change controls.

• Support system implementations and regulatory inspections, providing technical documentation and compliance input as needed.

• Communicate compliance risks and coordinate corrective actions with technical, operational, and cross-functional teams.

GENERAL REQUIREMENTS

• Thorough knowledge of current Good Manufacturing Practices (cGMP), FDA requirements, and 21 CFR Part 11.

• Strong understanding of CSV methodologies, computerized-system lifecycle documentation, and data integrity expectations.

• Ability to evaluate technical and compliance risks and recommend practical solutions.

• Strong project management, organizational, and technical problem-solving skills.

• Ability to work independently, manage priorities, and influence cross-functional teams.

• Excellent communication skills in English and Spanish, including reading, writing, and speaking.

EDUCATION & EXPERIENCE

• Bachelor’s degree in Science; a degree in Computer Systems or Engineering is preferred.

• Minimum of four (4) years of experience in computerized system validation and data integrity within pharmaceutical manufacturing operations.

• Demonstrated experience supporting laboratory, sterile, and non-sterile operations.