How will you make an impact?
The Manufacturing Technician II, based in San Clemente, CA, will perform all activities with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality system regulation (QSR) medical device good manufacturing practices (GMP) requirements.
What will you do?
The Manufacturing Technician II, based in San Clemente, CA will be responsible for the following:
· Prepare components and build assemblies
· Prepare bulk drug formulations
· Perform the following:
- Filing, capping, and crimping operations
- Packaging and labeling operations
- Sampling
- Visual inspections
· Documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR)
· Track clean room, environmental chambers, and equipment preventive maintenance (PMs)
Additional responsibilities will include:
· Perform basic calculation and data entry; Assemble, disassemble, and clean process equipment; Clean, etch, passivate, assemble, and inspect components
· Process and assemble components in accordance with documented specifications and procedures and prepare operations for:
- Bulk drug formulation
- Filling, capping and crimping
- Packaging and labeling
· Perform in-process inspection of assemblies and finished products in accordance with specification criteria
· Ability to perform validation activities (IQ/OQ/PQ/TMV/PV) as well as routine equipment preventative maintenance (PM)
· Coordinate with approved vendors daily/weekly/monthly/quarterly additional activities, collect vendor certificates, and complete documentation
· Use Microsoft Word, Excel and Oracle to complete document reviews, training, check inventory, and create forecasts
· Organize and clean the work areas: clean room, production areas, laboratory areas, and warehouse
· Perform additional duties and projects as required to facilitate Operations, Engineering, Clinical, and Quality Assurance goals and objectives
How will you get here?
To be successful in this role, you will need to have the following industry (medical device, pharmaceutical, and/or biotechnology) and educational experience.
It is highly desirable to have experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards.
Level - II
- 3 – 6 years’ experience with high school diploma
- 2 – 4 years’ experience with associate degree in science or engineering
- 0 – 2 years’ experience with bachelor’s degree in science or engineering
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.
Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we’re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Check out our profile on The Muse to get an inside look at our company culture. Glaukos Corporation has been Certified as a Great Place to Work the last two years!
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Job Type: Full-time
Pay: $22.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Supplemental pay types:
Ability to commute/relocate:
- San Clemente, CA 92672: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Manufacturing: 1 year (Preferred)
Shift availability:
Work Location: In person