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Technical Project Coordinator
2 months ago
Position: Technical Project Coordinator
Location: New Albany, OH
Contract Duration: 12 months
Ideal Candidate Profile: The preferred candidate should possess a background in engineering or a related technical field (mechanical, industrial, chemical, etc.). A proven track record of leading technical initiatives from inception to completion is essential, with experience in process development. Familiarity with biotech, medical devices, pharmaceuticals, or other GMP manufacturing environments is highly desirable. A minimum of 3 years of relevant experience is preferred. Candidates should demonstrate ownership of projects throughout their entire lifecycle. Proficiency in project management tools such as Smart Sheets, MS Project, or similar applications is advantageous.
Role Overview: As a vital member of the Process Development team, this position functions as the project coordinator for the introduction of new processes related to Final Drug Products (NPI). The scope of NPI may encompass the implementation of various drug product formats (e.g., vials, syringes, auto-injectors, etc.), the introduction of innovative processes and equipment (including final assembly and testing of medical devices), and the establishment of new packaging configurations.
Key Responsibilities:
- Evaluate NPIs to identify necessary modifications in processes, facilities, equipment, materials, and training.
- Develop comprehensive project execution plans.
- Ensure effective transfer of process requirements into manufacturing.
- Coordinate and execute NPI activities, which may involve document preparation or revision, change control management, manufacturing process adjustments, equipment and technology implementation (from design to qualification), and support for manufacturing readiness initiatives.