Job description
Position Profile:
This position is responsible for providing quality technical support, documentation and validation testing of production for custom automated converting, packaging, and coating equipment.
Essential Functions:
- Write validation test protocols and technical reports.
- Perform monitoring, sampling, and testing to validate equipment, systems, and processes per validation test protocols.
- Create and analyze validation documents such as FMEA, FDS, SDS, IQ, OQ, etc.
- Coordinate validation activities with other team members for completion within the established project timeline.
- Provide impact assessments for any changes made to validated equipment, systems, and processes; and execute any identified revalidation actions to maintain the validated status.
Education and Experience:
- Bachelor’s degree in engineering or other relevant technical discipline
- 3-5 years of experience in validation of manufacturing equipment and/or software validation
- Experience in achieving project goals in a leadership role
Competencies:
- Positive Teamwork Orientation
- Customer/Client Focus
- Experience with Microsoft Office products, Adobe Creative Suite, FrameMaker
- Experience with quality testing, advanced engineering, or validation testing for medical/pharmaceutical
- Ability to learn new software programs quick and efficiently
- Thorough with details and capable of managing multiple tasks
- Communication Proficiency (Verbal and Written)
- Basic knowledge of mechanical and electrical systems, pneumatics, and hydraulics
- Basic blueprint/schematic comprehension
Position Type, Work Environment & Travel
- Full time, exempt
- Normal office environment
- Periods of time spent in machine assembly environment testing equipment
- Possible travel obligations may arise
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