Job description

About Eyenovia

Eyenovia is a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology. Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. Visit http://eyenovia.com/to learn more.

Position Description

Position Title:Manufacturing Technician II (Pharmaceutical/Biotech). Agency Contract. Temp and temp-to hire positions

Department: Manufacturing

FLSA Status:Hourly

Scope of Job

Job Summary:

Reporting to the Production Manager, this role will be a key contributor on the Manufacturing team at Eyenovia and will follow defined tasks in the Manufacturing Department related to aseptic filling, preparation of assemblies/components, autoclave operation, visual inspection, shipping/receiving, and production activities. The Manufacturing Technician II will be present in the production process, meet deadlines, and be an active participant in issue reporting and resolution.

Receives Direction From: Production Manager

Provides Direction To: N/A

Essential Functions

To include, but are not limited to the following:

Direct Contributor

• Performing and Supporting Production Operations:
• Perform manufacturing operations per cGMP.
• Operating aseptic processing equipment.
• Product visual inspection.
• Performing in‑process inspections of components/materials, and assemblies.
• Monitor equipment parameters and results of in process inspection; make equipment adjustments, as necessary, according to procedures to ensure product meets specifications.
• Isolator and filler setup:
• Performing line clearance, parts washing, setting-up equipment, performing filter testing, autoclave operation, VHP of Isolator, and aseptic filling.
• Documentation:
• Real time batch record/logbook entries using Good Documentation Practices. Reviewing batch records to ensure good documentation practices are followed.
• Overtime and weekend work may be required.
• Aseptic cleaning of cleanrooms required. Facility/equipment cleaning required.
• Shipping/Receiving, ERP entries.

Collaboration

• Working/collaborating with supporting departments. For example, Engineering, Quality Assurance, and external vendors.

QUALIFICATIONS GUIDELINES

Any combination equivalent to, but not limited to, the following:

Education/Training/Experience

• High school diploma or equivalent.
• Minimum of 2 years of experience in aseptic processing in a pharmaceutical or biotech environment.
• Knowledge of vial visual inspection
• Demonstrated history performing Good Documentation Practices (GDP), legible, clear, and concise data entry into batch records, logbooks
• Understanding of aseptic technique.
• Display understanding of aseptic filling operations, equipment operation and media fills.

Knowledge/Skills/Abilities

• Ability to read, understand written instructions.
• Highly motivated, goal-oriented achiever with ability to prioritize and independently organize work.
• Good mechanical intuition, attention to detail, excellent problem-solving skills, and organization skills.
• Proficiency with written and spoken English, strong written and verbal communication skills.

Physical Requirements

• Able to stand, walk and sit for extended periods of time.
• Able to climb stairs.
• Able to operate personal computer.
• Able to lift up to 50 lbs
• Must be able to pass visual inspection eye exams annually for visual acuity and color blindness.
• Any new hire is required to submit proof of full Covid-19 vaccination or a request for a medical or religious exemption by the employee's first day of employment with Eyenovia.

Training Requirements

Training in relation to company systems and procedures, as well as individual job duties will be provided by Eyenovia. The need for additional external training with respect to regulations, industry standards, etc. will be determined by employee’s supervisor, and provided as appropriate.

A file documenting employee training is maintained for each Eyenovia, Inc. employee.

Job descriptions change from time to time. The company retains the right, at its sole discretion, to modify information contained in this job description. Changes in job description will be discussed with the employee at or before implementation.

Eyenovia (NASDAQ:EYEN) is an equal opportunity employer. Eyenovia offers a competitive compensation package including medical/dental/vision, matching 401K, paid time off, and holidays.

Job Type: Full-time

Pay: $34.50 - $36.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

COVID-19 considerations:
Vaccination requirements

Ability to commute/relocate:

• Redwood City, CA 94064: Reliably commute or planning to relocate before starting work (Required)

Education:

• High school or equivalent (Preferred)

Experience:

• Aseptic Filling: 2 years (Required)
• Pharmaceutical/Biotech Manufacturing: 2 years (Required)
• Manufacturing: 2 years (Required)

Work Location: In person

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