Jobs at ISPV Inc.

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.

Leads commissioning and qualification strategy and execution for regulated pharmaceutical systems. Responsibilities include risk assessments, FAT/SAT, IQ/OQ/PQ protocols, characterization, GMP-compliant documentation, change control, deviations, CAPA, data integrity, validation reports, and cross-functional coordination with engineering, quality, manufacturing, supply chain, vendors, and contractors. Provides technical guidance and mentorship to junior engineers.

Manage manufacturing documentation in Veeva Vault or similar platforms, author technical documents, own change control activities, coordinate projects, and use Smartsheet or comparable project-management tools. Qualifications include advanced education or equivalent manufacturing operations experience, ranging from a doctorate to high school/GED with ten years of experience.

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.

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.

Performs on-the-floor plant quality assurance for cGMP manufacturing, including batch records, deviations, CAPAs, change controls, validations, audits, and inspections. Partners cross-functionally with manufacturing, quality, engineering, facilities, and other teams to maintain compliance and product quality. Supports continuous improvement, new product introduction, commissioning and qualification, computer systems validation, data trending, and regulatory interactions. Advises management on quality, compliance, supply, and safety risks while ensuring procedures, training, and documentation requirements are met.

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.

Owns and updates manufacturing procedures, evaluates process performance, drives process improvements, supports training and validation, ensures cGMP compliance, manages change controls, and participates in inspections, NPI activities, batch record alignment, risk assessments, and manufacturing process or equipment modification projects.

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.

Lead engineering projects to design and validate packaging and new equipment processes for pharmaceutical or medical device manufacturing. Manage equipment design, project execution, and validation activities. Must be bilingual (English/Spanish) and work standard daytime shift with possible overtime.

Lead and support sterile drug product manufacturing activities including aseptic filling, process characterization, validation (PPQ), technology transfer, and commercial process support. Author and execute validation protocols, investigations, and change controls. Analyze manufacturing data using statistical tools, drive process optimization, and work cross-functionally with Manufacturing, Quality, Engineering, and Regulatory while managing multiple projects and documentation.

Analyze, design, and implement manufacturing process improvements to increase capacity, reduce lead time and WIP, and improve fill rates. Conduct capacity analyses, model processes with simulation tools, establish and maintain KPIs, partner with cross-functional teams and suppliers, identify bottlenecks, and support Lean, Six Sigma, Kaizen, and value stream initiatives to ensure uninterrupted product supply.

Perform and lead validation activities in a highly regulated industry, support/produce technical documentation, and ensure scientific and regulatory compliance. Role requires advanced scientific credentials or equivalent years of experience and background in engineering or microbiology.

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.

Provide engineering support for pharmaceutical/biotech manufacturing: troubleshoot equipment and processes, supervise production performance, develop process modifications, support validations, deviations, qualifications, and new product introductions. Collaborate with cross-functional teams and work non-standard shifts as needed.

Work in a process development laboratory focusing on inspection (manual and automatic), packaging area activities, and incoming primary container evaluation. Support process development and lab-based testing in materials sciences/engineering/physics contexts.

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

Bioprocess engineering role focused on purification operations. Requires experience with chromatography and UFDF techniques and knowledge of biotechnology purification processes. Candidate must hold a BS in Engineering with two years' engineering experience or a Master's degree.

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