The Automation Engineer is to enable lean operations and automate manual processes wherever and whenever possible; they need to leverage many different type of technology to automate code releases as well as internal processes.
As the Quality Automation Engineer, you will write and maintain test automations, develop quality assurance standards, and define and track quality assurance metrics such as defect densities and open defect counts.
In this role, you will provide support for the automated systems (hardware) used in plant operations at the large scale cell culture facility. This includes directly implementing changes, as well as providing technical expertise to others in the organization.
In this role, you will participate in cross functional teams from manufacturing, manufacturing technology, utilities, facilities, quality assurance and validation departments to develop requirements, recommendations and business justification for system modifications.
In this role, you will create test plans, write test cases and organize them in a test management tool. The selected candidate will create automated tests and systems within an overall continuous integration environment.
In this role, the selected candidate must be an individual with extensive knowledge of medical device quality system regulations (i.e. FDAs Quality System Regulation and ISO 13485) and the ability to develop, implement and maintain a quality system compliant with these requirements.
The Automation Lead is responsible for the management of and technical direction to a team of automation engineers and contractor resources to ensure the successful implementation of all automation systems in the ACMF/Building E- at the Pharmaceutical Andover Site.