Jobs at ISPV Inc.

The QA Specialist is responsible for environmental monitoring, data evaluation, regulatory compliance, and continuous improvement in quality management systems in a pharmaceutical setting.

Provide engineering support for biotechnology/pharmaceutical drug substance processes and GMP manufacturing systems. Work with SAP, TrackWise, electronic batch records (PAS/X), and Veeva to support production and document controls.

Support biotechnology/pharmaceutical drug substance manufacturing and GMP systems. Provide process support for drug substance operations, maintain GMP-compliant manufacturing systems, and use SAP, TrackWise, electronic batch records (PAS/X), and Veeva document management.

Design, implement, and improve inspection systems for parenteral and glass containers. Maintain automated and manual inspection equipment, lead technical teams, support validation and documentation in a regulated environment, and communicate technical information in English and Spanish.

Manage deviation lifecycle in a GMP/GxP environment: own major/minor deviations, lead investigations, use Veeva QMS to create and close records, apply structured problem-solving, support CAPA development and effectiveness verification, maintain inspection-ready documentation, and assess deviations involving computerized manufacturing systems (MES, SAP, PCS, PI Historian).

The role involves overseeing the planning and execution of pharmaceutical facility projects, ensuring adherence to GMP and safety regulations, managing stakeholders, and controlling costs.

Develop and deploy AI/ML solutions for manufacturing process and task optimization. Provide manufacturing support, build models (ML/DL/LLMs), integrate AI into operational environments, perform statistical analysis, produce technical documentation, follow GDP and quality systems, and collaborate with cross-functional teams to ensure compliant, quality-oriented implementations.

Senior engineering role focused on GMP compliance: investigate clean utilities, manage GMP investigations and deviation documentation. Requires an engineering degree with specified years of experience (Doctorate+2, Masters+4, Bachelors+6).

Principal Engineer role focused on engineering within GMP-regulated environments. Preferred experience in clean utilities, GMP investigations, and deviation documentation. Requires an engineering degree with relevant years of experience.

This role involves developing C&Q strategy, overseeing commissioning activities, executing qualification protocols, ensuring compliance with regulatory standards, managing risk assessments, and collaborating with cross-functional teams in the engineering and pharmaceutical sectors.

Review and reclassify real vs. personal property accounts, split asset history/ledger, update the asset tax ledger, and document finance department procedures. Position requires strong Excel skills and accounting experience in statutory audits and financial statement preparation.

Review and reclassify real and personal property accounts, split asset history/ledger between real and personal property, update the Asset Tax Ledger, and support documentation of finance department procedures. Short-term (2–3 month) assignment based in Barceloneta, PR for a fourth-year accounting student or recent graduate. Microsoft Excel proficiency required; familiarity with AI tools like Copilot is desirable.

Lead pharmaceutical capital projects from concept through commissioning and close-out. Develop execution plans, schedules, budgets, and resource plans; manage A/E firms, contractors, procurement, change control, QA/validation, and safety. Coordinate across Operations, Engineering, Quality, Sourcing, and Finance to deliver projects on time, within scope and budget, ensuring regulatory compliance, documentation, risk mitigation, and readiness for operations. 15% travel; requires BS in Engineering and extensive pharma capital experience.

Support manufacturing operations by developing and revising SOPs, managing CAPA and change control, implementing process improvements, and training operators to ensure compliant production on 8-hour shifts.

Support biotech manufacturing operations through deviations management and assessments, maintain track-wise quality records, and apply manufacturing experience to ensure compliant production. Role requires shift availability and possible overtime.

Perform data science and analytics using Python, R, SQL and visualization tools. Work with enterprise data platforms, data warehousing, data modeling and integration (Databricks, EDW, SAP, MES). Support Industry 4.0 initiatives (IoT, digital twins, real-time analytics) to derive insights and build analytics solutions.

Support occupational safety and environmental programs across manufacturing sites, focusing on ergonomics, risk assessments, ISO 45001/14001 management system activities, regulatory compliance, audits, training, and continuous improvement while flexing across multiple EHS responsibilities.

The role involves troubleshooting automation processes, PLC programming, maintaining control systems, and supervising work teams in an industrial automation setting.

The Specialist QA role involves executing quality disposition of drug substances, ensuring compliance with cGMP, managing deviations and changes, supporting audits, and overseeing new product introductions while championing continuous improvement efforts.

The Sr Engineer will handle engineering practices in pharmaceutical production, including technical writing and vendor management while ensuring compliance with cGMP procedures and validation practices.