Business Analyst, Laboratory CSV Specialist

Full Time Contract

Title or Role : Business Analyst / Lab CSV Specialist

Location : Barceloneta, PR

Length of Contract : months

Company Description :

Our client is a global, research-driven biopharmaceutical company focused on developing advanced therapies for some of the world's most complex and serious diseases. Our Barceloneta, PR site plays a critical role in our manufacturing and supply chain operations, producing innovative medicines that impact patients' lives worldwide.

Position Description :

We are looking for a highly motivated and skilled IT Business Analyst with specialized expertise in the validation of laboratory systems to join our team in Barceloneta, PR. This critical role serves as a key liaison between our laboratory operations (, Quality Control, Analytical Development, R&D Labs) and IT, ensuring that our computerized laboratory systems are not only efficient and meet business needs but are also fully compliant with stringent regulatory requirements, particularly GxP and CFR Part . You will be instrumental in driving the full lifecycle of laboratory system implementations, from requirements gathering through robust validation and ongoing support.

Responsibilities

• Laboratory System Requirements & Validation Elicitation : Act as the primary interface between laboratory scientists, quality assurance, and IT technical teams for laboratory system projects. Conduct in-depth interviews, workshops, and process analysis specifically focused on laboratory workflows, data integrity, and compliance needs. Translate complex analytical and scientific requirements into clear, concise, and detailed functional, non-functional, and validation requirements for laboratory information management systems (LIMS), chromatography data systems (CDS), electronic lab notebooks (ELN), lab instrument software, and other GxP-critical lab applications. Develop and maintain comprehensive documentation, including User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Traceability Matrices, and other essential documentation required for computer system validation (CSV) in a GxP environment. Ensure all documentation adheres strictly to GxP, FDA, CFR Part , Annex , and other relevant regulatory guidelines.
• System Analysis, Solution Design & Compliance : Analyze existing laboratory IT systems and processes to identify gaps, risks, and opportunities for improvement in terms of efficiency, data integrity, and regulatory compliance. Collaborate with IT architects, developers, and vendors to design, configure, and implement robust and compliant laboratory solutions. Apply a deep understanding of data integrity principles (ALCOA+) to all aspects of system design and implementation. Incorporate knowledge of laboratory best practices and regulatory mandates into system recommendations and designs.
• Laboratory System Implementation, Testing & Validation Execution : Lead and participate in the development of validation strategies, validation plans, IQ / OQ / PQ protocols, and test scripts specifically for laboratory systems. Execute and oversee rigorous system testing, including FAT, SAT, IQ, OQ, PQ, and User Acceptance Testing (UAT), ensuring all validation requirements are met and documented. Author and review Validation Summary Reports and other validation deliverables. Manage and investigate deviations and discrepancies identified during validation and operational phases, ensuring timely resolution and corrective actions. Provide ongoing support and expertise to end-users on validated laboratory applications, troubleshoot complex issues, and manage system lifecycle activities.
• Compliance, Audit Readiness & Training : Ensure all IT solutions and processes for laboratory systems are fully compliant with applicable Corporate and Divisional Policies, procedures, and pharmaceutical industry regulations (, FDA, GxP, ISO standards). Actively participate in and support internal and external regulatory audits (, FDA inspections) related to computerized laboratory systems, serving as a Subject Matter Expert (SME) on system functionality and validation status. Develop and deliver comprehensive training programs to laboratory personnel on new or updated validated systems, emphasizing compliant system usage and data integrity.
• Project Leadership & Continuous Improvement : Lead and manage IT projects or significant workstreams specifically focused on laboratory system implementations, upgrades, or enhancements. Monitor project tasks, timelines, and deliverables, ensuring adherence to project plans and quality standards. Foster a collaborative environment, working effectively with cross-functional teams (IT, Lab Operations, Quality Assurance, Validation, Vendors). Stay current with industry trends, emerging technologies (, advanced analytics, automation in labs), and regulatory updates related to laboratory systems and validation.

Qualifications

Education

Equal Opportunity Statement :

RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Pay Transparency :

RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.

Disclaimer :

This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

About RCM :

RCM is a leading provider of Business, IT, and Engineering Services to over , clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.