| Validation Engineers at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3167861&uid=b148aa67160f459e8627135089cf01f3 From: Priyanshi Baghel, Vyze inc [email protected] Reply to: [email protected] Job Title: Validation Engineers Rockford, IL (Hybrid) Need local with DL Need LinkedIn Open to remote work up to 50% of the time for documentation but must live locally Target start date: April 6th, Would potentially take someone March 30th or 23rd Work schedule: Monday Friday 8am to 5pm 40-hour work week being on site such as protocol execution, equipment review, etc. Project description: They have recently expanded with two new sites and are scheduled to receive a bulk of medical device and assembly line equipment. One site expansion includes installation and validation of multiple high-speed automated assembly systems supporting combination products and autoinjector device manufacturing. The site will be commissioning and validating three MAYA automated needle safety device assembly systems which are Low-speed, multistation combination product assembly platforms, Two IMAS automated autoinjector assembly lines running at~40 units per minute (UPM) throughput and one OPTIMA high-speed autoinjector assembly system operating at ~100 units per minute (UPM). The other facility is the high volume facility where there will be three assembly lines capable of producing 300 ppm each and multiple packaging lines there as well. They are needing to bring in additional Validation Engineers to be responsible for Equipment installation oversight (post-FAT, during/after SAT), development and execution of IQ/OQ/PQ protocols, validation of automated mechanical, pneumatic, and servo-controlled systems, integration with vision inspection and reject systems, verification of alarm handling and interlocks and documentation compliance and inspection readiness. Much of this activity will be taking place beginning April 1st and is expected to last roughly 8 months. Over the first 30 days the resources will be partnered with other validation engineers to learn about the internal environment as well as putting together a plan for how they will qualify the equipment as well as partnering with their customers to ensure that their programs have been properly incorporated into these new efforts. They will join a small team of a director, 3 other validation engineers and some entry level resources. Required Skills: 5+ years of GMP validation experience in medical device or combination product manufacturing Experience validating high-speed automated mechanical, pneumatic, or servo-controlled systems/filling lines. Direct hands-on writing and executing IQ/OQ/PQ on automated assembly systems or high-speed assembly lines Strong deviation investigation and technical writing experience Consultants day to day responsibilities: Author, review and execute Installation Qualification (IQ) protocols Author, review and execute Operational Qualification (OQ) protocols Support Performance Qualification (PQ) execution Verify equipment installation against URS and design specifications Perform utility verification (compressed air, electrical, vacuum, etc.) Verify safety interlocks and emergency stop functionality Validate servo motor calibration and motion profiles Challenge alarm conditions and fault recovery scenarios Validate vision inspection system functionality and reject logic Document deviations and author validation discrepancy reports Interface with OEM engineers during SAT and troubleshooting Ensure compliance with CFR Part 11 (where electronic batch systems exist) Coordinate with QA for protocol approval and report finalization Keywords: quality analyst Illinois Validation Engineers [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3167861&uid=b148aa67160f459e8627135089cf01f3 |
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| 07:06 AM 26-Feb-26 |