What are the responsibilities and job description for the Validation Engineer position at Randstad Global Capability Center?
Looking for US Citizens and Green Card
Description :
Qualified candidates must be experienced in one or more of the following areas of validation :
- Equipment Qualification
- Process Qualification
Responsibilities associated with this position are directly associated with the introduction and launching of new equipment or products and processes into a manufacturing facility. The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process. The candidate must possess technical writing experience in protocol generation and procedure generation. Some experience is required in master plan generation and the change control life cycle. The candidate must be a team player who thrives in a team environment, but also has the capability to work on their own to research and investigate. Gown qualification is a plus, with an understanding of clean room practice and cGMP environments. The qualified candidate must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.
SUPERVISION RECEIVED
Under direct supervision of Manager, Quality Engineering.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty
Satisfactorily :
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and / or ability required for this position.
