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C oordinate the smooth workflow for the plant’s overall validation program and provide technical support to the Columbus Plant. The position is self-directed with input coming from all Engineering, Operations, and Quality Assurance staff members. Excellent communications and human relation skills are essential; organizational skills and attention to detail are equally vital. The role involves extensive collaboration with others so as to drive information flow or decisions regarding validation.
- Supporting the creation of systems, programs, and libraries for managing validation, calibration, and technical documentation.
- Managing the plant Validation Review Board process. This includes scheduling, facilitating, and publishing meeting minutes for VRB (Validation Review Board) as well as routing, tracking, and filing validation documents.
- Preparing, executing, and gaining approval of validation protocols and reports.
- Working with project engineers to ensure compliance on new validation packages
- Monitor and control the site’s active validation portfolio by monitoring status and approving action plans to close on them on time.
- Demonstrate accountability and responsibility for Environmental Health and Safety performance and compliance through active participation and support of Abbott’s EHS program.
- Responsible for implementing and maintaining the effectiveness of the Quality System.
- Perform other work related duties as assigned.
Bachelor’s degree in engineering or technical field is required.
2+ years of experience in engineering/ project management or advanced education to achieve level of skill.
- Background in the execution of validation activities in a regulated manufacturing environment is required (preferable nutritional product experience).
- Project management experience desired.
- Good communication skills, both written and verbal required.
Interfaces with production team members, department managers, and Division Engineering / QA functions.
Receives general supervision and exercises some discretion as to work details. May determine technical objectives of assignments; exercises some latitude in approach to problem solving.
Leads small project teams / supports larger programs to successful completion. Responsible for completing projects tasks within time and budget constraints. Prepares design specifications and recommendations for presentation and approval.
Identifies and quantifies technical risks and their consequences relative to the success of a project; recommends appropriate action, e.g. reports calculations and recommendations in terms concrete enough for management to make an informed decision.
This job is performed in a regulated quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
This person has some latitude to determine day-to-day work priorities dependent on successful completion of all assigned work within time limits imposed by Engineering Staff.