Medical Device Manufacturing Technician
Franklin, WI

Job Summary
Purpose:
Under direct supervision, performs the filling, packaging, and support in aseptic and non-aseptic clean room environment (Class 100 to 100,000) in accordance with cGMP\'s (current Good Manufacturing Practices) and other applicable regulatory requirements, such as ISO and OSHA.
Duties & Responsibilities:
- Follow written SOP’s, batch records and work instructions to perform the key silicone forming processes that include:
- Dipping – forming parts from manually dipping a mold core into silicone
- Stripping parts – pulling silicone parts from mold cores without tearing parts
- Texturing – applying texture to silicone parts
- Patching – visually aligning and sealing silicone shells
- Filling – using syringe to precisely fill silicone shells
- Preparation of cleaning solutions for sanitization of facility, equipment, and materials for aseptic and non-aseptic for production use
- Labeling, packaging, inspection of parts and monitoring curing and sterilization processes
- Legibly and accurately record the completion of tasks on routers (and potentially computer or touch screens) or other forms
- Apply attention to detail while performing all assigned tasks - for example: manually forming parts
- Be willing to be trained to perform other duties as needed by production, such as mixing silicone
- Adhere to strict clean room standards: hairnets, no make-up, gloves, gowning, GMP
- Be willing to be trained to use instruments for measurement
- Understand and follow the instructions per applicable routers and guidance documents (QOP, SOP, MOP, etc)
- Maintain hazardous waste according to EH&S procedures
- Other duties as assigned
- Starting job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments
Skills & Abilities:
- High school diploma or general education degree required
- Experience in Biotech/Pharmaceutical and cGMP experience and/or training; or equivalent combination of education and experience is preferred
- Prior experience with aseptic processing, and FDA interactions is highly desirable
- Experience with assembly, sanitization, and clean room practices is a must
- Experience in an aseptic clean room class 100 environment a plus
- Able to convert units of measurement, add, subtract multiply and divide
- Ability to multi-task and interact well with others
- Strong interpersonal and communication skills with the ability to communicate effectively at all levels
- Team player with good communication skills and customer focus
- Accuracy and attention to detail
- Ability to secure and maintain a favorable background investigation and clearance
Education & Experience:
- High school Diploma or GED equivalent

- Franklin, WI
- Production
- Full Time
- Head of Medical Device Manufacturing
Tiger BioSciences and its subsidiaries are proud to be an equal opportunity workplace. All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, military or veteran status, genetic information, or any other characteristic protected by applicable law.