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# 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, Data Processing
- **Published:** October 2, 2026
- **Apply:** https://jobs.mitalent.org/job-seeker/job-details/JobCode/412152882

## 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

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.


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