Job Title: Engineer
Reports To:
Sales Engineer
Summary:
The Engineer will be involved in a variety of tasks including design, fabrication, evaluating and troubleshooting
of parts, internal fixtures, machines, and processes. The Engineer will work closely with both the production
personnel for improvement projects and the sales team on new opportunities.
Duties and Responsibilities include the following. Other duties may be assigned.
1. Process improvement initiatives for fabrication and assembly processes including evaluation and
installation of new equipment.
2. Validation, training and start-up of new systems using GMP techniques (IQ, OQ, PQ).
3. Maintenance plans for critical equipment necessary for continued operation of the manufacturing
departments. Systems include: HVAC, hydraulic crimpers, bag sealers, pressure testers and cleanroom
areas.
4. Create CAD drawings for final assemblies, custom components and work area layouts.
5. Development of manufacturing plans and proposals for both internal expansion projects as well as
customer opportunities.
6. Develop protocols and execute a variety of tests to support new product development or respond to
customer requested information.
7. Participate in corrective/preventive action (CAPA) response teams including root cause analysis, testing
and implementation of corrective actions.
8. Comply with ISO and cGMP regulations.
Qualifications:
1. Bachelors degree in engineering or similar discipline or associates degree in a technical field with 2-5 years
related experience.
2. 1-2 years’ experience working in cGMP and/or ISO certified environment
3. Experience in manufacturing/assembly operations in cleanroom environments
4. Self-motivated with a strong work ethic and the ability to multitask
5. Proficiency in all MS Office products, specifically Word, Outlook, and Excel
6. Strong attention to detail
7. Exceptional communication skills with proven ability to interface with multiple departments
8. Working knowledge of CAD
9. DOE, FMEA, and IQ/OQ/PQ knowledge is highly desired
Completing the Connection for High Purity Fluid Handling
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