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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Operations Technical Specialist - **Company:** Grand River Aseptic Manufacturing - **Location:** Grand Rapids, MI, United States - **Experience:** Starter - **Contract:** Permanent contract - **Skills:** Microsoft Word, Microsoft Excel, Microsoft Outlook, Automated Information System (AIS), Data Processing - **Published:** August 18, 2026 - **Apply:** https://diversityjobs.com/main/sendform/8/8/28176/1/17978726?backUrl=%2Fcareer%2F17978726%2FOperations-Technical-Specialist-Michigan-Grand-Rapids ## About the Role * Bachelor's degree in life sciences, engineering, or equivalent training and/or experience is necessary. * Entry level experience (0-3 years) in pharmaceutical manufacturing. * Must have proficient computer skills in Microsoft Word, Excel and Outlook. Preferred Requirements: * Previous experience in a CMO and sterile filling, manufacturing, and/or fill finish environment is preferred. * Strong aptitude in root cause analysis, technical writing and CAPA in a GMP environment; LEAN/six-sigma experience is a plus. ## Description The OTS Specialist executes routine technical support activities for GMP Manufacturing Operations across multi-product, Manufacturing, Fill, and Finish CDMO facilities. Activities include cross-functional deviation investigations, CAPAs, AIs, targeted innovations, audit support, and overall plant performance. Support is for all local GRAM sites and the position works closely with Quality as well as Operations, Continuous Improvement, Engineering, MSAT, and Project Management to support site objectives. This is an on-site role. Must be able to work an on-call schedule for technical supports and site deviation analysis, as needed., * Work closely with respective team members from Operations, Engineering, Maintenance, Project Management and Quality to ensure all documentation (and respective data) is gathered in an expeditious manner for timely completion of deviation investigations. * Ensure appropriate risk analysis, root cause and corrective action tools and identification is used for all deviation investigations. * Author and revise site procedures in a timely manner to address CAPA and corrective actions for deviation investigation and/or site continuous improvement projects. * Assess, evaluate, and provide immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis, and reporting. * Serve as first line of defense for all operations excursions, GMP lifecycle management of execution level process data, providing for unit operation (i.e., formulation, manufacturing, sterile filling, inspection/labeling). * Support strategic plans for process and plant improvements to increase efficiency and manage costs. * Effective cross-functional collaboration with Quality, Continuous Improvement, MSAT, AMAs, MPEs, SCM, Operations Supervision, and Management. * Assist engineering and validation with implementation, commissioning, and validation of clean room spaces and process equipment as well as inspection and packaging process equipment. * Take corrective action by thinking creatively and problem solving to develop innovative solutions based on sound scientific analysis. * Initiate revisions to cGMP procedures, and master batch records as applicable. * Initiate daily, weekly, and monthly site quality metrics and trend reviews. * Assist in the review and approval of Validation documents and site change controls. ## Related Videos - [Remote Driving on Plant Grounds with State-of-the-Art Cloud Technologies](https://www.wearedevelopers.com/videos/251-remote-driving-on-plant-grounds-with-state-of-the-art-cloud-technologies) - [Developing the Rich Text Editor for DeepL.com](https://www.wearedevelopers.com/videos/1172-developing-the-rich-text-editor-for-deepl-com) - [In-depth .NET Azure Functions: Isolated mode, performance and durable AI agents](https://www.wearedevelopers.com/videos/100207-in-depth-net-azure-functions-isolated-mode-performance-and-durable-ai-agents) - [Implementing continuous delivery in a data processing pipeline](https://www.wearedevelopers.com/videos/73-implementing-continuous-delivery-in-a-data-processing-pipeline) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [From Syntax to Singularity: AI’s Impact on Developer Roles](https://www.wearedevelopers.com/videos/900-from-syntax-to-singularity-ai-s-impact-on-developer-roles) ## Related Articles - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Quick guide: How to write a Software Developer CV](https://www.wearedevelopers.com/magazine/37-quick-guide-how-to-write-a-software-developer-cv) - [Is Software Engineering Over-Saturated?](https://www.wearedevelopers.com/magazine/418-is-software-engineering-over-saturated) - [Generating ODF Files in JavaScript — Without LibreOffice](https://www.wearedevelopers.com/magazine/752-generating-odf-files-in-javascript-without-libreoffice) - [A Guide to Green Tech and Green IT Careers](https://www.wearedevelopers.com/magazine/374-a-guide-to-green-tech-and-green-it-careers)