Validation Engineer

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 $64.00 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. Technical Operations & Support 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. Training & Process Optimization 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. Inspection & Packaging Equipment Involvement 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. Qualifications & Skills 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. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law. Allen Mudalel (610) 828-7356 amudalel@jsginc.com 515 Grove St. Suite 3G

• Haddon Heights, NJ 08035
• jsginc.com