Jobs at QRC Group, LLC

Designs, implements, and executes scientific experiments to support process development projects under supervision. Works on drug product manufacturing, process validation, and authors technical protocols and reports. Collaborates cross-functionally and applies engineering principles when relevant.

Lead characterization and optimization of manufacturing equipment and processes. Own CMMS activities, improve reliability and availability, reduce downtime, develop performance metrics, lead equipment improvement projects, act as SME for design/maintenance, support troubleshooting, manage CAPAs and deviations, and drive EHS compliance.

Designs, implements, and executes experiments to support biopharmaceutical process development. Provides technical support to commercial manufacturing (formulation and aseptic filling), monitors processes, analyzes data (JMP), supports investigations and root-cause analysis, prepares regulatory documentation, and provides on-floor 24/7 manufacturing support while collaborating cross-functionally. Bilingual Spanish/English required.

Lead and manage process development projects across cross-functional teams, ensuring cGMP and regulatory compliance. Develop business cases, identify and mitigate risks, apply lean Six Sigma and continuous improvement, allocate resources, document work per SOPs, and support non-standard shifts to meet timelines and quality goals.

Lead development and execution of commissioning and qualification strategy for packaging systems. Oversee FAT/SAT/field commissioning, author and approve IQ/OQ/PQ protocols, ensure URS traceability, maintain GMP/FDA/EMA compliance and ALCOA+ data integrity, manage risk assessments and change control, coordinate cross-functional teams, and mentor junior engineers.

Support process engineering for pharmaceutical manufacturing recapitalization, BCP, equipment lifecycle, capital projects, commissioning/qualification, validations, CAPA, investigations, and continuous improvement while ensuring quality, safety, and environmental compliance.

Lead investigations of deviations, non-conformances, and quality events in a regulated manufacturing environment, ensuring compliance and effective CAPAs.

Lead and deliver multiple complex projects from initiation to close, focusing on manual production line operations, validation, and technology implementations. Develop plans, budgets, and timelines; manage risks; coordinate cross-functional teams and stakeholders; ensure compliance, quality, and alignment with business objectives.

Support biotechnology/pharmaceutical drug substance processes and GMP manufacturing systems. Provide process engineering support, technical writing, and use SAP, TrackWise, PAS/X, and Veeva. Bilingual Spanish/English required.

Manage and execute facilities and utilities engineering projects, coordinating contractors and internal teams to deliver designs, installations, commissioning, and qualification. Monitor timelines, budgets, and compliance with safety, environmental, and regulatory standards (e.g., GMP). Drive continuous improvement and maintain technical documentation and project plans.

Responsible for developing and implementing safety programs, risk assessment reviews, and identifying safety systems for equipment.

Lead data science projects and collaborate with business partners to deliver analytics solutions. Develop models and visualizations using Python/R/SQL and tools like Power BI and Databricks. Work with enterprise data platforms, data warehousing, data modeling and integration (EDW, SAP, MES). Apply Industry 4.0 concepts (IoT, digital twins, real-time analytics). Bilingual (Spanish/English).

The Senior Project Manager will lead diverse projects, manage production lines, ensure compliance, develop project plans, and communicate with stakeholders.

Lead the QA investigations to ensure compliance and effective resolution of quality events in a regulated environment while managing workflows and metrics.

The Industrial Engineer will lead lean manufacturing initiatives, optimize processes, calculate financial savings, and apply Six Sigma methodologies in a regulated environment.

The Scheduler coordinates project activities, manages procurement tracking, and maintains schedules, ensuring alignment of deliverables and timelines in an FDA regulated environment.