US, US, OH - Dayton
Minimum Level of Education Required: Associates Degree
Percentage of Travel: No travel required
Location: OH - Dayton
* Provides support for projects which includes but not limited to the introduction of new equipment, new processes, changes in processes, equipment upgrades and improvements.
* Support validation activities IQ, OQ ,PQ of equipment, product or processes as required. This can include installation, EHS inspection, drawing verification, instrumentation verification, calibrations, measurements and / or functional testing.
* Performs troubleshooting, repairs and maintenance of production, packaging and utilities equipment and controls systems, following the established company guidelines, equipment operational procedures, site and manufacturer recommendations
* Work with operations daily to increase equipment up time and reduce un-planned downtime
* Support Clean Room monitoring and certifications as required.
* Utilize appropriate Problem Solving and Troubleshooting techniques to complete equipment repairs.
* Complete documentation required for maintenance following records retention using quality system guidelines in order to ensure product quality.
* Maintain manufacturing equipment according to Company Good Manufacturing Practices (GMP) and procedures in order to assure the quality of the manufactured product.
* Ensure adherence to safety, operating policies and GMP using Company policies and procedures.
* Bachelors, Associates or post-secondary technical degree, computer skills, and documentation skills and maintenance experience.
* 3-5 years of experience in a manufacturing / sterile packaging environment
* Strong verbal communications as demonstrated in the context of the interviewing process
* Strong interpersonal skills as demonstrated in the context of the interviewing process
* Technical/Mechanical inclination as demonstrated in the context of the interviewing process Verifiable references
* Willing and able to learn new job specific skills
* Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.
* Utilizes various instruments and other specialize tools to detect, troubleshoot and repair electrical equipment or systems
* Working knowledge of manufacturing, assembly, cleaning, packaging, utilities and inspection equipment.
* Controlled environment experience