The Role
Supports commercial pharmaceutical and biotechnology manufacturing operations, with emphasis on sterile injectables, drug-device combination products, packaging, labeling, troubleshooting, investigations, process validation, and GMP quality systems. Leads projects, authors technical documentation, analyzes process performance, supports improvements and technology transfers, and provides on-floor technical guidance. Collaborates with Manufacturing, Quality, Engineering, Validation, Maintenance, Automation, Supply Chain, and Regulatory teams. Requires an engineering degree, relevant experience, and full English-Spanish bilingual proficiency.
Summary Generated by Built In
We are seeking a Sr. Engineer with:
- Direct experience providing technical or process-development support to commercial pharmaceutical, biotechnology, medical-device, or combination-product manufacturing operations.
- Experience managing projects
- Experience with sterile injectable products, prefilled syringes, auto-injectors, pens, or other drug-device combination products.
- Direct knowledge of packaging operations, including primary and secondary packaging, labeling, cartoning, and packaging-line troubleshooting.
- Proven ability to investigate inspection rejects, packaging defects, yield losses, equipment alarms, and process deviations using structured root-cause-analysis tools.
- Experience authoring or reviewing technical protocols, study reports, engineering assessments, investigation reports, risk assessments, work instructions, and change controls.
- Knowledge of process qualification and validation activities, including equipment qualification (IQ/OQ/PQ), process performance qualification, test-method validation, and continued process verification or process monitoring.
- Basic experience using statistical and data-analysis tools to assess process performance, including trend analysis, control charts, process capability, variability assessments, and establishment of monitoring limits.
- Direct experience with GMP-regulated manufacturing and quality-system processes, including deviations, CAPAs, non-conformances, complaints, change controls, and data-integrity requirements.
- Experience collaborating cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, Maintenance, Automation, Supply Chain, and Regulatory Affairs.
- Experience supporting process improvements, equipment upgrades, new product introductions, technology transfers, or implementation of new inspection and packaging technologies in a commercial environment.
- Ability to provide effective on-the-floor support, communicate clearly with operations personnel, and make timely, data-driven technical decisions while maintaining compliance and product quality.
Requirements
- Education: Doctorate or Master's degree + 2 years of Engineering experience or
Bachelors in Engineering + 4 years of Engineering experience. - Fully Bilingual (English & Spanish)
Skills Required
- Direct technical or process-development support experience in commercial pharmaceutical, biotechnology, medical-device, or combination-product manufacturing operations
- Project management experience
- Experience with sterile injectable products, prefilled syringes, autoinjectors, pens, or other drug-device combination products
- Knowledge of primary and secondary packaging, labeling, cartoning, and packaging-line troubleshooting
- Experience investigating inspection rejects, packaging defects, yield losses, equipment alarms, and process deviations using structured root-cause-analysis tools
- Experience authoring or reviewing technical protocols, study reports, engineering assessments, investigation reports, risk assessments, work instructions, and change controls
- Knowledge of process qualification and validation, including IQ/OQ/PQ, process performance qualification, test-method validation, and continued process verification or monitoring
- Basic experience with statistical and data-analysis tools, trend analysis, control charts, process capability, variability assessments, and monitoring limits
- Direct experience with GMP-regulated manufacturing and quality systems, including deviations, CAPAs, nonconformances, complaints, change controls, and data integrity
- Cross-functional collaboration with Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, Maintenance, Automation, Supply Chain, and Regulatory Affairs
- Experience supporting process improvements, equipment upgrades, new product introductions, technology transfers, or new inspection and packaging technologies
- Ability to provide effective on-floor support and make timely, data-driven technical decisions while maintaining compliance and product quality
- Doctorate in Engineering
- Master's degree in Engineering plus at least 2 years of engineering experience
- Bachelor's degree in Engineering plus at least 4 years of engineering experience
- Fully bilingual in English and Spanish
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
