Works as part of a team performing standard engineering work requiring application of standard engineering techniques, procedures and criteria. Work is closely supervised.
The candidate will primarily support key engineering projects through the creation and approval of engineering protocols, special reports, First of Code protocols, and final reports. The candidate will also support validation of production equipment including IOQ, PQ/PV, software and test method protocols. Candidate is also expected to support of various engineering projects. Lead product and process improvement CAPA projects with minimal supervision, managing cross-functional teams to timely and effective closure.
Performs routine engineering assignments of related tasks which are typically a focused portion of larger projects. These tasks provide experience and familiarization with the engineering staff, methods, techniques, theories, Corporate and division SOP's, policies and projects.
Document development work including writing specifications for manufacturing or scientific test results.
Ability to solve routine design and engineering tasks with some assistance.
Able to solve problems with periodic monitoring.
Assists in the preparation and participation in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.
Support other Quality and Engineering work - e.g. process validation, test method development and validation, supplier engagement - as required.
Assisting engineers with their routine projects and work and performing validations as needed.
Support engineering studies; work in cleanroom, engineering builds, etc. as needed.
Ability to discuss normally encountered technical or project management issues, both verbally and in written form.
Ability to work as a collaborative team member.
Ability to solve routine design, engineering problems with assistance
Prefer experience with TQM methods (e.g. "six sigma")
Demonstrated application of engineering principles on individual/small projects
Demonstrated ability to effectively run projects, coordinates contractors, and directs the activities of a technician.
Hands-on experience leading CAPA projects in regulated environment.
PHYSICAL DEMANDS & WORK ENVIRONMENT:
The physical activity of this position
Standing. Particularly for sustained periods of time.
Walking. Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
Talking. Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers.
The physical requirements of this position
Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the worker sits most of the time, the job is rated for light work.
Experis is an Equal Opportunity Employer (EOE/AA)
Resolve Technical Issue
Provide Technical Guidance
Engineering Design Process