Offre d’Emploi à Porto Rico : Business Analyst, Laboratory CSV Specialist

Présentation de l’Offre

Titre du poste : Business Analyst, Laboratory CSV Specialist
Entreprise : RCM Technologies
Localisation : Barceloneta, PR
Type de contrat : Contrat à temps plein, 6 mois

À Propos de l’Entreprise

Notre client est une entreprise biopharmaceutique mondiale axée sur la recherche, spécialisée dans le développement de thérapies avancées pour des maladies complexes et graves. Le site de Barceloneta, PR, joue un rôle crucial dans les opérations de fabrication et de chaîne d’approvisionnement, produisant des médicaments innovants qui impactent la vie des patients à l’échelle mondiale.

Description du Poste

Nous recherchons un Analyste Commercial motivé et qualifié, avec une expertise spécialisée dans la validation des systèmes de laboratoire. Ce poste essentiel sert de liaison entre nos opérations de laboratoire (Contrôle Qualité, Développement Analytique, Laboratoires R&D) et l’IT. L’objectif est d’assurer que nos systèmes informatisés de laboratoire soient non seulement efficaces et adaptés aux besoins de l’entreprise, mais également conformes aux exigences réglementaires strictes, en particulier GxP et 21 CFR Part 11.

Responsabilités Clés

Validation et Élicitation des Exigences des Systèmes de Laboratoire :

• Agir en tant qu’interface principale entre les scientifiques de laboratoire, l’assurance qualité, et les équipes techniques IT pour les projets de systèmes de laboratoire.
• Conduire des interviews et des analyses de processus centrées sur les flux de travail de laboratoire, l’intégrité des données, et les besoins de conformité.
• Transformer les exigences analytiques et scientifiques en spécifications fonctionnelles et de validation claires pour les systèmes de gestion des informations de laboratoire (LIMS) et autres applications critiques GxP.

Analyse des Systèmes et Conception de Solutions :

• Analyser les systèmes et processus IT de laboratoire pour identifier des lacunes et des opportunités d’amélioration.
• Collaborer avec les architectes IT et les développeurs pour concevoir des solutions de laboratoire robustes et conformes.

Exécution de Tests et Validation :

• Diriger le développement et l’exécution de stratégies de validation et de protocoles de tests pour les systèmes de laboratoire.
• Assurer le respect des exigences de validation et documenter les résultats.

Conformité et Audit :

• Participer activement aux audits réglementaires, en agissant en tant qu’expert en la matière pour les systèmes informatisés de laboratoire.
• Développer des programmes de formation pour le personnel de laboratoire sur l’utilisation conforme des systèmes validés.

Qualifications Requises

• 5+ années d’expérience technique directe en tant qu’Analyste Commercial, avec une solide expertise en systèmes de laboratoire.
• Expérience démontrée dans la validation des systèmes informatisés pour des environnements réglementés GxP.
• Compréhension solide des principes d’intégrité des données (ALCOA+).
• Diplôme en Informatique, Systèmes d’Information, Biotechnologie, ou discipline scientifique connexe.

Égalité des Chances et Transparence des Salaires

RCM est un employeur garantissant l’égalité des chances. Tous les candidats qualifiés seront considérés pour l’emploi sans discrimination. RCM s’engage à fournir des salaires compétitifs, reflétant les compétences et l’expérience des employés.

Avis de Responsabilité

Cette annonce vise à décrire la nature générale et le niveau de travail à effectuer. RCM se réserve le droit de modifier les responsabilités en fonction des besoins organisationnels.

Postulez dès maintenant !

Cette présentation vise à respecter les standards éthiques et techniques tout en fournissant toutes les informations pertinentes sur l’offre d’emploi.

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📅 Date de publication de l’offre : Thu, 29 May 2025 22:20:59 GMT

🏢 Entreprise : RCM Technologies

📍 Lieu : Barceloneta, PR

💼 Intitulé du poste : Business Analyst, Laboratory CSV Specialist

💶 Rémunération proposée :

📝 Description du poste : Full Time ContractTitle or Role: Business Analyst/Lab CSV Specialist
Location: Barceloneta, PR
Length of Contract: 6 monthsCompany 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 (e.g., 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 21 CFR Part 11. 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, 21 CFR Part 11, Annex 11, 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 (e.g., FDA, GxP, ISO standards).
• Actively participate in and support internal and external regulatory audits (e.g., 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 (e.g., advanced analytics, automation in labs), and regulatory updates related to laboratory systems and validation.

Qualifications

• 5+ years of direct technical experience as a Business Analyst with a strong focus on laboratory systems (LIMS, CDS, ELN, instrument software) within the pharmaceutical, biotechnology, or a highly regulated manufacturing industry.
• Demonstrated in-depth experience in Computer System Validation (CSV) for GxP-regulated laboratory systems, including authoring and executing validation protocols (IQ/OQ/PQ) and related lifecycle documentation.
• Solid understanding and practical application of GxP, 21 CFR Part 11, and data integrity principles (ALCOA+).
• Experience with specific laboratory system platforms (e.g., LabVantage LIMS, Empower CDS, NuGenesis ELN, Waters, Agilent, Thermo Scientific systems) is highly desirable.
• Strong experience in systems testing and IT implementation within a regulated environment.
• Project Management experience is highly preferred.
• Exceptional analytical and problem-solving skills, particularly for complex laboratory processes and data flows.
• Strong understanding of the System Development Life Cycle (SDLC) and GAMP 5 guidelines.

Education

• Bachelor’s degree in Computer Science, Information Systems, Biotechnology, Chemistry, Biology, or a related scientific/engineering discipline.

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 1,000 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.

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