Primary Responsibility for execution of bulk product batch processing, inclusive of all process related and administrative activities, as well as Equipment Preparation activities as declared in Compounder 1.
The Senior Engineer - Technical Project Lead is responsible for managing strategic / technical engineering projects in a cGMP environment through planning, organizing, and controlling all elements of the project. Have the ability and competency to oversee all facets of the projects, inclusive but not limited to URS development, equipment procurement, installation, qualification and financial oversight. Apply engineering principles to support operational initiatives such as equipment reliability enhancement, environmental sustainability, project execution standardization and continuous improvement. Ability to work in a fast-paced environment and the competence to concurrently handle multiple projects and operational initiatives. This position is exempt from overtime.
Primary Responsibility for execution of bulk product batch processing, inclusive of all process related and administrative activities, as well as Equipment Preparation activities as declared in Compounder 1.
The Process Mechanic will perform activities including, but not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and process machinery while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. This position may also include light facilities maintenance.
The ability to read, write and speak English is a requirement of the job.