MINARIS MEDICAL AMERICA
OPTIGEN Manufacturing Associate Technician I
The OPTIGEN Manufacturing Associate Technician I position is located in Mountain View, CA. This position will use current Good Manufacturing Practices to perform a variety of production line tasks to include equipment set-up, cleaning and operation, part assembly, labeling, packaging, inspections, and lot accountability. Work is performed in a manufacturing environment. The person in this position may be exposed to blood serum, hazardous chemicals and loud noises. The incumbent will receive general instructions for routine work.
The OPTIGEN Manufacturing Associate Technician I will maintain batch records and work environment to comply with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures.
Essential Duties and Responsibilities
- Assist in the validation of equipment, processes, and tools in manufacturing
- Clean and maintain work area and equipment. Perform line clearances and inspect components
- Communicate effectively with co-workers and supervisor
- Communicate with supervisor and lead regarding any excessive damaged or substandard assembly work and defective parts, tools, equipment, material or other conditions which hinder assembly process
- Follow and provide feedback on Standard and Manufacturing Operating Procedures, Work Instructions, Manufacturing Batch Records
- Respond in a timely manner to manufacturing needs. Repair, maintain, operate, and troubleshoot production and test equipment.
- Package and assemble diagnostic test kits; operate production line machinery and computers according to cGMP, batch records, Manufacturing Operating Procedures and safety policies
- Reject and segregate parts that do not meet specifications according to documentation
- Support preventative maintenance program for OPTIGEN manufacturing equipment according to schedule and ensure preventative maintenance is properly documented
Position Requirements (Knowledge, skills and abilities required to perform satisfactorily in the position)
- Working knowledge of cGMP requirements
- Ability to follow instructions and communicate clearly and concisely in English, both orally and in writing
- Basic knowledge and experience with PC and MS applications (Microsoft Excel, Word and Outlook are required)
- Basic reading, writing, arithmetic, and critical thinking skills
- Detail oriented, with good mechanical skills
- Manual dexterity required for quick and accurate assembly of small parts and operation of equipment
Education and Experience
- High School Diploma (Prefer AS or equivalent college course work in Chemistry or Life Sciences)
- Minimum one (1) year hands-on technical experience in a cGMP Manufacturing environment of the biotech or pharmaceutical industry
- Manufacturing environment
- Dry temperatures (occasional)
- Loud noises (occasional)
- Potential exposure to human blood serum ozone, and hazardous chemicals
- Machinery operation requires the use of safety equipment to include, but not limited to eye safety glasses, slip-resistant safety shoes, and hearing protectors
- Frequently lift up to 15 pounds (for up to 2 hours at a time and up to 8-10 hours total in a day)
- Frequent use of hands (for up to 2 hours at a time and up to 8-10 hours total in a day)
- Long periods of standing (continuously for up to 2 hours at a time and up to 8-10 hours total in a day)
- Ability to visually discern printed characters as small as 1/16”; Close and distant
Position type and expected hours of work
Full-time. Must be able to work flexible schedules (including nights, weekends, overtime) as needed.
Affirmative action plan/equal employer opportunity (AAP/EEO) statement
Minaris Medical America, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, marital status, pregnancy, sex, gender expression or identity, sexual orientation, citizenship, genetics or any other legally protected class. In addition to federal law requirements, Minaris Medical America, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. Minaris management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary, at any time with or without notice.