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.

Manage supplier relationships through engagement, cross-functional leadership, and project management. Ensure supplier performance and quality standards. Role requires relevant degree-plus-experience combinations (Quality/Supplier Engagement experience).

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).

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.

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.

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.

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

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.

Manage deviations documentation and change control processes within manufacturing operations while ensuring compliance with industry regulations.

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 overseeing packaging systems, performing engineering evaluations, and ensuring compliance with industry standards. Candidates should have strong project management and communication skills and be able to work independently and in teams.

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.

Seeking an Associate Tech Engineer with experience in mechanical equipment, PLC systems, and vision system troubleshooting in a cGMP environment.

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.

The role requires expertise in documentation, procedure revision, QMTS Trackwise, CAPA's, audits, and laboratory knowledge within manufacturing operations.

The Process Development Scientist creates validation and qualification documentation, supports vision inspection qualification, and communicates with suppliers. Knowledge in automated vision inspection systems and CSV is a plus.