JSG (Johnson Service Group, Inc.)
JSG (Johnson Service Group, Inc.) is hiring: Automated Visual Inspection in Alba
JSG (Johnson Service Group, Inc.), Albany, NY, US
A validation and quality assurance provider are looking to hire a Automated Visual Inspection & System Validation Engineer for their Albany, NY project site. This unique group works to develop and blueprint a universally implemented validation process that reliably achieves quality, affordable and available healthcare products. Hourly rate $70.00 Key Responsibilities System Validation & Compliance
- Develop and execute IQ/OQ/PQ protocols for automated visual inspection systems and integrated components, including camera systems, lighting, HMI, and defect libraries.
- Perform Computer System Validation (CSV) activities in alignment with GAMP 5 guidelines, ensuring data integrity, audit trail compliance, and secure user access controls.
- Validate defect detection capabilities through challenge set development, false rejection/acceptance tuning, and statistical sampling.
- Ensure adherence to regulatory requirements including FDA 21 CFR Part 11, EU Annex 1, and internal quality management standards.
- Troubleshoot performance issues, lead root cause investigations, and implement corrective actions for vision system failures, false positives/negatives, and inconsistent defect detection.
- Support system integration with MES, SCADA, and LIMS platforms.
- Partner with QA, Engineering, and Manufacturing teams on equipment startup, FAT/SAT, process improvements, and CAPA activities.
- Author and revise system documentation including SOPs, URS, FS, RTM, risk assessments (e.g., FMEA), and validation reports.
- Support the transition from manual to automated inspection platforms through validation, change control, and performance benchmarking.
- Develop and deliver training for operators and quality inspectors, ensuring robust SOPs and job aids are established.
- Identify and implement process improvements to enhance inspection accuracy and reduce false rejections using data-driven methodologies.
- Provide validation and operational support for inspection equipment used in sterile fill/finish processes, including Vial Washers, Depyrogenation Tunnels, Vial Fillers with Isolators, Lyophilizers, Autoclaves, and packaging systems (Cartoners, DFU Inserters, Label Printers, Tape Sealers, Stretch Wrappers, Vacuum Lifts).
- Conduct smoke studies, unidirectional airflow visualization, EMPQ, glove integrity testing, and validation activities within Grade A, B, C, and ISO 5/7/8 cleanroom environments.
- Deep technical knowledge of automated visual inspection systems, validation principles, and CSV.
- Proven ability to drive process improvements, conduct troubleshooting, and ensure regulatory compliance.
- Strong collaboration skills and experience working with cross-functional teams.
- Solid understanding of regulatory requirements with the ability to communicate compliance measures effectively.
- Hands-on experience with validation, risk assessments, and system documentation in a GMP-regulated environment.