Jobs at ISPV Inc.

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

Perform commissioning, qualification, and validation (IOQ, PQ, functional tests) of manufacturing and laboratory equipment; author and review technical documents and reports; manage quality systems (deviations, change control) and maintenance documentation (PMs, work orders, job plans); ensure process and cleaning validation documentation is reviewed and approved.

Support regulated biotech/pharma manufacturing by applying process engineering and automation knowledge to troubleshoot issues, implement CAPA, drive continuous improvement (Lean Six Sigma/Kaizen), ensure cGMP compliance and documentation, and collaborate with operations, quality, and maintenance teams to optimize production.

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.

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.

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.

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

Supports process development in manufacturing by optimizing equipment, troubleshooting issues, ensuring product quality, and participating in continuous improvement projects.

Lead strategic projects in a manufacturing setting, ensuring new product launches meet contract goals while managing cross-functional teams and compliance with quality standards.

Support and own manufacturing process change controls, lead deviation and root cause investigations, design and execute process/challenge tests, support CAPA/BOM/MBR activities, enable campaign readiness, create training/materials, and drive process improvement and documentation in a regulated bioprocessing manufacturing environment.

Perform and support bioprocessing unit operations with root-cause analysis and lean manufacturing methods. Maintain Good Documentation Practices in a regulated environment, use Trackwise/VEEVA/MES and analytics tools, prepare technical writing/presentations, collaborate with manufacturing/process development/quality teams, work under minimal supervision and high workload, and be available for extended hours and overtime as needed.

Support formulation and aseptic filling operations in a commercial biopharmaceutical manufacturing environment. Monitor processes, trend data, perform statistical analysis (JMP), investigate deviations, conduct root cause and product impact assessments, provide manufacturing floor support (including irregular shifts), prepare regulatory audit documentation, and collaborate cross-functionally. Bilingual English/Spanish communication and strong technical writing and project management skills required.

Coordinate cross-functional supply chain projects, set timelines and priorities, create/analyze/present metrics, manage product and material requirements, monitor processes and metrics, track spend and cost-reduction opportunities, ensure cGMP and SOP compliance, support audits/investigations, maintain training, and implement controlled document changes.

Develop and validate drug product manufacturing processes, perform process validation activities, and write technical protocols and reports to support product development and commercialization.

Manage and assess manufacturing deviations, perform deviation investigations and assessments, support track-wise manufacturing activities in a biotech production environment. Requires manufacturing operations experience and may involve overtime; 8-hour shift, administrative duties included.

Support equipment and system decommissioning in a regulated manufacturing environment. Manage technical documentation, change control, risk and impact assessments, and regulatory compliance. Coordinate cross-functional teams, oversee commissioning/decommissioning activities and asset lifecycle, drive continuous improvement, and provide technical troubleshooting while meeting project deadlines.

Own manufacturing equipment lifecycle in CMMS, optimize maintenance and reliability, define PM and spare strategies, lead improvement projects, troubleshoot equipment, support deviations and CAPAs, and ensure EHS and compliance adherence.