Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Roles & Responsibilities:
- Writing and execution of validation protocols and reports (ie. IQ, OQ, PQ, etc.)
- Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation
- Updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system.
- Working with OEM equipment manufacturers and distributors to develop user requirements.
- Work on new asset commissioning
- Working with multi-functional teams (Operations Value Stream, OpEx, Planning, Engineering, and Quality) to align on validation strategy, author validation documents, coordinate execution and document approvals.
- Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects.
- Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.
Education & Experience:
- 2-4 years of experience in manufacturing and/or process engineering.
- Strong technical writing skills, with appropriate awareness of intended audience.
- Ability to effectively communicate across multiple audiences, including operators, peers and management, in both written and oral manners
- Process validation experience.
- Experience in a Medical Device and/or regulated manufacturing work environment.
- Persuasive communication and interpersonal skills.
- Digital literacy, including use of Microsoft Office tools.
- Experience working in a regulated industry, such as Medical Device.
- Experience with machining processes, metal finishing processes, laser processing or production automation.
- Hands-on experience with machining processes, casting, metal finishing processes, laser processing or production automation.
- Knowledge of statistical data analysis and associated tools (e.g. Minitab).
- Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T).
- Willingness to support global projects, which may include travel.