Sr. Manufacturing Technician
The Sr Manufacturing Technician will be responsible for the manufacturing and in-process testing for IVD products at the San Juan Capistrano facility. Such activities will include among others:
- Manufacturing of product,
- troubleshooting,
- Equipment maintenance
- metrics trending,
- execution of validation activities and
- document creation and revisions
- Manufacturing and assembly of IVD products and kits, and coordination of manufacturing schedule for SJC site manufactured products.
- Creation and revision of label templates in bartender. Implementation of label templates ensuring adequate process controls.
- Conduct process validation runs as part of commercial manufacturing support.
- Revision and creation of manufacturing related procedures. Endure adequate and accurate documentation of device history records, instrument records, PM records etc.
- Support implementation of continuous improvement activities.
- Execute equipment preventive and corrective maintenance to keep production equipment operational.
- Help with troubleshooting of problems within the manufacturing process.
- Create reports and analyze production data / information.
- Ensure all manufacturing related areas are kept organized and clean and in good housekeeping conditions (inclusive of materials areas)
- Ensure full compliance with IVD FDA and ISO requirements.
- Ensure all required training is done on time.
QUALIFICATIONS
Required Work Experience:
- Minimum of five (5) years’ experience in Laboratory and/or Manufacturing
Preferred Work Experience:
- Minimum of five (5) years’ experience in IVD / pharmaceutical or medical device in Manufacturing or Laboratory
- Laboratory Technician
Physical and Mental Requirements:
- Prolonged Pipetting and ELISA plate set ups
- Focused attention
- Prolonged sitting
Knowledge:
- FDA and ISO regulations and requirements
- Quality processes and systems
- Manufacturing / Laboratory process and systems
Skills:
- Good record keeping skills
- Laboratory analytical skills (pipetting, reagents, etc.)
- Instrumentation skills (plate reader/washers, incubation ovens, shakers, etc.)
- Analytical and problem-solving skills
- PC literate (excel, word, Minitab, PowerPoint, etc.)
- Understand the requirements of a QSRs Quality System. ISO-13485 and GMP environment.
EDUCATION
Associates Degree(Required)
Bachelor’s Degree
LICENSECERTIFICATIONS
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.
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