Location: Waltham, MA
Essential Duties and Responsibilities:
- Perform system walk downs to identify/confirm manufacturer, model number, and serial number for major system components
- Identify critical spares for major components per OEM recommendations
- Compare part numbers against current inventory
- Support the administrative process of preparing part data for upload to our SAP system
- Support the sourcing of new parts including contacting vendors and obtaining quotes
- Perform maintenance assessments to ensure GMP compliance, alignment across like-systems and optimize the maintenance strategy of critical systems
- 3+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast paced multitasking environment.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.