JobWatch

19 days old

Lead Manufacturing Operator

Kelly Services
Redwood City, CA 94061
**Lead Manufacturing Operator | Redwood City, CA**


**_Kelly Services is hiring a Lead Operator for a clinical stage ophthalmic company developing a pipeline of advanced therapeutics_** based on its proprietary microdose array print (MAP) platform technology. The company currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. **Seeking candidates with cGMP + aseptic filling experience!**


**Pay** : ~$38-42/hour - DOE


**Shift** : Mon-Fri w/ start time of between 6:30am-8am, 8-hr shift; OT available


**Job Summary** : Reporting to the Production Manager, this role will be a key contributor on the Manufacturing team at Eyenovia. The Lead Operator will be responsible for assisting the Production Manager in coordinating the day-to-day activities for production activities. The Lead Operator will be present on the production floor, assist the Production Manager with production activities, meet scheduling requirements, train, and qualify staff for aseptic filling operations, and be the primary conduit for reporting issues arising from filling activities


_Supervision_


Supervising and performing Aseptic Filling, equipment/component preparation, packaging, and drug product visual inspection per department/company procedures.


Leading the efforts of their production team(s) to comply with the companys policies and procedures, including quality, safety, environmental, and business practices.


_Direct Contributor_


+ Setting-up of Production Lines

+ Performing line clearance, parts washing, setting-up equipment, performing filter testing, autoclave operation, and aseptic filling.

+ Performing and Supporting Production Operations

+ Operating aseptic processing equipment.

+ Performing in process inspections of components/materials, assemblies.

+ Monitor equipment parameters and results of in process inspection; make equipment adjustments, as necessary, according to procedures to ensure product meets specifications.

+ Train new staff on aseptic processes, equipment preparation, filter testing, autoclave operations.


_Documentation_


- Real time batch record/logbook entries and reviewing batch records to ensure good documentation practices are followed.


_Collaboration_


- Working/collaborating with supporting departments (Engineering, Product Development, Quality Assurance) and vendors.


QUALIFICATIONS GUIDELINES


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


+ High school diploma or equivalent.

+ Minimum of 4 years of experience in **aseptic processing and/or filling** in a pharmaceutical or biotech environment.

+ Knowledge in FDA/EU **aseptic processing regulations**

+ Knowledge of vial visual inspection

+ Successful experience adhering to valid **manufacturing procedures** and documentation

+ Demonstrated history performing legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a **cGMP process**

+ Proven experience maintaining a high level of quality and compliance with regards to all aspects of manufacturing

+ Aseptic technique

+ Display understanding of filling operations, equipment operation (fill machines, filling pumps), and aseptic media fills.

+ May Have/Preferred Experience successfully starting/scaling up a new facility, including equipment qualification. Experience with single use processing equipment.


_Skills_


+ Ability to read, understand and 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.

+ Ability to work collaboratively across all functional groups and all levels.

+ Proficiency with written and spoken English, strong written and verbal communication skills.


_Physical Requirements:_


+ Standing, sitting, walking, stairs, light lifting, computer operation

+ Eyenovia is an equal opportunity employer. Eyenovia offers a competitive benefits package including medical, dental, PTO, and holidays.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-05-06 Expires: 2022-06-06

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Lead Manufacturing Operator

Kelly Services
Redwood City, CA 94061

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast