Reading Metro Area, Pennsylvania
Ideal candidate should be familiar with working in a GMP environment as it relates to medical device manufacturing and with writing, executing and routing charters, feasibility studies, validation protocols, risk assessments and other project documents and specifications. Candidate must to have current experience using recent versions of Microsoft Word, Excel and Visio programs. The ideal candidate also has experience establishing productive working relationships within a cross-functional team, including employees from various inter-facility departments (quality, purchasing, materials, etc.) and can work productively without supervision.
Provide support to various engineering-based projects within an office environment; may be required to complete tasks in production areas. Apply technical writing skills in the form of protocols, test procedures, summary reports, flow charts, specifications and other documents as required.
Duties include the following activities under the guidance of a project manager and/or engineering manager:
- Create and revise various types of technical documents
- Work with Manufacturing Engineers, Supervisors and production staff to create/revise process work instructions
- Create and distribute meeting minutes to document issues, resolutions and action items; follow-up on action items with responsible person(s)
- Work with the Manufacturing Engineers as needed to prepare/complete documents, specifications and reports; may support completion of documents/tasks for pending projects
- Track document review and approval routings; accurately track status of multiple documents
- Work with Manufacturing Engineer(s) relative to dimensional and mechanical features as needed for protocols, reports, specifications, work instructions, etc.
- Communicate with internal employees and external suppliers as needed
- 3-5 years in a position demonstrating development, coordination and control of technical documentation activities per standards associated with a strictly regulated manufacturing environment
- Proficiency in Microsoft Office Suite
- Excellent interpersonal and written communication skills
- Excellent organizational and time management skills
- Ability to work independently and within a team as needed
- Flexibility to work in an office and production environment (may include clean room environment)
- 5+ years in a GMP medical device environment
- Statistical analysis experience with software
- Experience with 2D drawing and/or 3D modeling software
- Experience working in a clean room environment
- Demonstrated ability to work on multiple projects simultaneously and appreciation for deadlines
Associates Degree in Technical Writing, Communication or Engineering Technology