Jobs at ISPV Inc.

Develops and reviews pharmaceutical quality and regulatory documents, including PQRs and DMFs, ensuring cGMP and regulatory compliance. Supports site projects, product introductions, transfers, equipment and systems qualification, process validation, change controls, investigations, deviations, CAPAs, supplier notifications, batch records, and SOPs. Requires pharmaceutical industry experience, knowledge of FDA, EU, and CFR 21 regulations, and proficiency with SAP, TrackWise, and Microsoft Office.

Commission and qualify parenteral product, vision system, device assembly, and packaging processes across automatic and high-mix low-volume production lines. The role requires either a doctorate, a master’s degree with two years of engineering experience, or a bachelor’s degree in engineering with four years of engineering experience.

Supports environmental health and safety activities for capital projects, equipment installations, shutdowns, startups, and regulated industrial facilities. Applies EH&S regulations, risk management, process safety, hazardous-gas controls, machine safeguarding, LOTO, construction safety, and fire and life safety practices. Reviews engineering drawings and technical specifications, manages multiple projects, prepares technical communications, and uses Microsoft Office and EH&S management systems. English/Spanish bilingual ability is required.

The Senior Engineer supports pharmaceutical and biotech final-product packaging and manufacturing. Responsibilities include evaluating primary and secondary packaging materials, applying GMP and GDP standards, conducting distribution and technical testing, writing protocols, performing technical evaluations, and preparing reports supporting packaging component selection. The role requires project management, problem-solving, communication, teamwork, and adaptability in an evolving environment.

Owns and executes supplier-related Change Control quality records with minimal supervision. Leads cross-functional meetings to drive timely progression and closure, evaluates supplier quality records using critical thinking, and coordinates stakeholders to deliver results. Requires strong Change Control expertise, effective communication, collaboration, and hands-on experience with TrackWise and SAP.

Manage quality complaints using project management, root cause analysis, and CAPA determination. Apply strong quality and compliance knowledge while documenting and coordinating work through Microsoft Office, Excel, Outlook, and Teams.

Perform biotechnology purification operations using chromatography and UFDF techniques. The role requires an engineering degree, with either a master’s degree or a bachelor’s degree plus two years of engineering experience. Work hours are 8:00 AM to 5:00 PM.

Supports pharmaceutical and biotech production processes, facilities, and equipment as a system owner. Applies cGMP and engineering practices, uses Maximo, handles purchase orders, coordinates and escorts vendors, manages multiple priorities, and provides occasional after-hours engineering coverage for 24/7 operations.

Oversee manufacturing operations while working directly with manufacturing operators. Manage document creation, review, approval, and document management activities. Candidates must be available to work different shifts and meet education and manufacturing operations experience requirements.

Performs pharmaceutical quality assurance and validation activities, including facilities and utilities commissioning, computer system validation, equipment validation, risk assessments, change controls, SOP management, data integrity, documentation review, and syringe/vial inspection processes. Uses KNEAT, CDOCS, SCADA, TrackWise, and MAXIMO systems while applying risk management and decision-making techniques.

Supports drug product manufacturing and process improvement through data analysis, dashboard development, statistical evaluation, GMP documentation, validation, automation, and digital tool development. The role translates ambiguous operational challenges into sustainable solutions and may support characterization studies, engineering runs, PPQ, validation deliverables, and manufacturing readiness activities.

Support manufacturing systems by entering recipes into packaging equipment, assessing automation, determining correct recipe parameters, and providing system support primarily on first shift with occasional second-shift coverage.

Leads complex, cross-functional capital and product lifecycle projects from business case development through execution and launch. Responsibilities include change control, project controls, New Product Introduction, technology transfer, process development, commercialization, integrated schedules, resource plans, risk registers, budgets, and governance processes. A process validation background is beneficial. The role requires substantial project management experience based on education level, ranging from two years with a doctorate to twelve years with a high school diploma or GED.

Manage manufacturing documentation, including creating, reviewing, and approving documents. Collaborate directly with manufacturing operators and support manufacturing operations across different shifts. Candidates must meet one of the specified education and manufacturing operations experience combinations, ranging from a doctorate to high school/GED with extensive experience.

Manage multiple projects, priorities, and responsibilities under time pressure. Coordinate effectively in team or matrix environments, apply change control, and use project management software, spreadsheets, Ariba, SAP, and TrackWise. Communicate fluently in written and spoken English and Spanish, prepare presentations, maintain accurate organization, and support strategic project execution while demonstrating initiative and readiness for increased responsibility.

Manages multiple projects, priorities, and responsibilities under time pressure in a team or matrix environment. Uses project management software, spreadsheets, and Microsoft Office to organize work, communicate progress, and support presentations. Requires change control experience, strong analytical and organizational abilities, familiarity with Ariba Sourcing and Contracting Modules, and preferred experience with SAP and TrackWise. Fluency in written and spoken English and Spanish is required.

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.

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.

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