United Pharma Technologies Inc · 21 hours ago
System Validation Engineer
Albany, NY
Contract
Onsite
Mid LevelUnited Pharma Technologies Inc is seeking a highly skilled Automated Visual Inspection & System Validation Engineer to support sterile fill/finish and packaging operations. The role requires expertise in automated vision systems and validation methodologies, focusing on ensuring compliance with regulatory requirements and process optimization.
BiotechnologyData ManagementHealth CareMedicalPharmaceutical
Hiring Manager
Chinmai M
Responsibilities
Develop, execute, and document IQ/OQ/PQ protocols for automated visual inspection systems and integrated components, including cameras, lighting, HMIs, and defect libraries
Perform Computer System Validation (CSV) activities in compliance with GAMP 5 guidelines, ensuring data integrity, audit trail functionality, and secure user access controls
Validate defect detection performance through challenge set development, false reject/false accept tuning, and statistical sampling methodologies
Ensure compliance with regulatory requirements including FDA 21 CFR Part 11, EU Annex 1, and internal quality management systems
Troubleshoot system performance issues, conduct root cause investigations, and implement corrective and preventive actions (CAPA) related to vision system failures and detection inconsistencies
Support integration of automated inspection systems with MES, SCADA, and LIMS platforms
Collaborate with QA, Engineering, Manufacturing, and Automation teams during equipment startup, FAT/SAT, commissioning, and ongoing process improvements
Author, review, and maintain technical and validation documentation including SOPs, URS, FS, RTM, risk assessments (FMEA), and validation summary reports
Support transition initiatives from manual inspection to automated visual inspection platforms, including validation and change management activities
Develop and deliver training programs for operators and quality inspectors, ensuring clear SOPs, work instructions, and job aids are in place
Identify, analyze, and implement data-driven process improvements to enhance inspection accuracy and reduce false rejection rates
Qualification
Required
Strong technical expertise in automated visual inspection systems, system validation, and CSV
Hands-on experience executing validation activities in a GMP-regulated manufacturing environment
Solid understanding of FDA 21 CFR Part 11, EU Annex 1, GAMP 5, and data integrity principles
Proven ability to troubleshoot complex systems and drive continuous process improvements
Excellent collaboration and communication skills with cross-functional stakeholders
Experience developing and maintaining validation documentation, risk assessments, and SOPs
Company
United Pharma Technologies Inc
United Pharma Technologies (UPT) is a global life-science services company delivering CQV, validation, quality, automation, and regulatory compliance solutions to the pharmaceutical, biotechnology, medical device, and diagnostics sectors.
Founded in 2010
201-500 employees
H1B Sponsorship
United Pharma Technologies Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (50)
2024 (81)
2023 (77)
2022 (69)
2021 (46)
2020 (57)
Funding
Current Stage
Growth StageTotal Funding
unknown2022-07-18Acquired
Leadership Team
Babjee M
Founder/ Srategic Partner
Company data provided by crunchbase