Senior CSV 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 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 Senior CSV Specialist is accountable for the execution of the strategies for IT Computerized Systems, Computer System Validation (CSV) and Data Integrity, to assure site adherence to regulatory requirements and site procedures and methodologies. The position performs computerized systems validation for the site systems at the Sterile, Non-Sterile, Utilities, Facilities and QC/QA functional areas at manufacturing facility according to all Federal, International, State and Corporate Regulations. The position is responsible for the design, development and execution of software and computer validation protocols and computer validation plans for computerized systems supporting the site areas, and assures the systems are compliant with all CSV and data integrity requirements before releasing the system for its intended use.

Key Responsibilities

• Assures IT Compliance commitments (computer system validation, data integrity, quality compliance) are planned, closely monitored and completed as expected, following all applicable regulations.
• Keeps abreast of regulatory developments applicable to IT Systems, within or outside of the company, and evolves the department’s best practices in compliance control.
• Serves as the Site IT Subject Matter Expert for IT Compliance issues, including but not limited to Data Integrity, 21 CFR Part 11 for computerized systems, and computer system validation in support of laboratories, manufacturing, and packaging operations.
• Ensures the development, implementation, execution and sustainability of an efficient Software/Computer System Validation program for Business, Manufacturing and Quality Systems, aligned with regulatory requirements, Corporate Directives, and site policies.
• Ensures Periodic Reviews for computerized systems are completed as per plan and aligned with regulatory requirements, and site and corporate procedures.
• Develops and maintains an effective process to ensure system documentation (requirements, specifications, drawings, data mappings, qualification protocols and equipment manuals of computerized systems) is properly maintained.
• Identifies computerized systems validation needs through in-house assessments.
• Ensures the execution and sustainability of an efficient Data Integrity program for computerized systems supporting Business, Manufacturing, Utilities/Facilities, Packaging and Inspection Areas, aligned with regulatory requirements, Corporate Directives, and site policies.
• Performs data integrity assessment activities for new and existing site computerized systems and assures all risks are mitigated prior to system release.
• Leads the detection and evaluation of Data Integrity systems deficiencies for the implementation of corrective actions, which will assure correct operation and compliance with regulatory agency requirements.
• Ensures execution plans for computerized system validation, SDLC for eBRs and Data Integrity compliance are performed as per regulatory requirements, and site and corporate commitments.
• Provides recommendations to remediate or mitigate data integrity findings in computerized systems, implements and validates modifications, and assures the systems are maintained in compliance with regulatory requirements.
• Develops computerized systems data mappings to assure these are maintained in alignment with site operations and in compliance with regulatory requirements.
• Fosters creative problem solving and provides technical guidance on computerized systems situations, including data integrity.
• Assures timely closure of incidents, investigations, audit observations, CAPAs and/or change controls for quality computerized systems.
• Communicates to management potential Data Integrity systems situations that can affect quality or compliance, to ensure appropriate management action is taken to correct these problems.
• Supports regulatory agency inspections on IT Compliance and Data Integrity requirements.
• Supports the implementation of computer systems and provides guidance to assure compliance with Data Integrity requirements and all regulatory requirements, company policies and procedures.

Qualifications and Required Knowledge/Skills

• Bachelor’s Degree in Science (Computer Systems or Engineering preferred).
• Thorough knowledge of cGMP, FDA and Data Integrity regulations is a must.
• Experience with computerized system validation methodologies, 21 CFR Part 11, and Data Integrity regulations.
• Minimum of four (4) years of computerized system validation and data integrity experience within pharmaceutical manufacturing operations.
• Proven experience supporting laboratory, sterile and non-sterile operations.
• Proven skills in project management.
• Ability to impact and influence people and areas within the company to deliver superior business results.
• Excellent communication skills (oral, written and reading) in Spanish and English.

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.