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17 days old

Lead Operator - Days

Kelly Services
Carlsbad, CA 92008
**At Kelly** **** **Professional & Industrial, were passionate about helping you find a job that works for you. How about this one?** Were seeking a Lead Operator to work at an industry-leading bio-pharmaceutical manufacturing client of ours in Carlsbad, CA. With us, its all about finding the job thats just right.


**Why you should apply to be a Lead Operator:**


+ Long-term opportunity with a well-known, reputable company!

+ Pay Rate: $26-$27/hr DOE

+ 12 hour Day Shift: 4 on, 3 off, 3 on, 4 off (incorporates weekends) 7am-7pm


+ Weekly electronic pay options

+ Access to outstanding Kelly perks via https://www.mykelly.us/us-mykelly/perks/


**Whats a typical day as a Lead Operator?**


**Position Summary:**

This position requires routine hands-on bioprocess manufacturing within a cGMP cleanroom. The individual will use their technical expertise, training, and qualifications while strictly following defined procedures. Responsibilities include performing bioprocess manufacturing activities and operating bioprocessing equipment, meticulous documentation of performance, monitoring of processing equipment, processes, and control systems within a cGMP cleanroom. The Manufacturing lead operator is expected to lead by example, demonstrate flexibility, think outside the box, keep the cGMP cleanroom in a constant state of inspection readiness and perform routine tasks such as cleaning, chemical and waste management, equipment maintenance, materials movement and other duties as assigned to assure the cleanroom and manufacturing systems are clean and inspection-ready at-all-times. The individual will adhere to all Safety and Quality standards of the organization and will contribute to continuous improvement in the areas of Safety, Quality, and Delivery.


**Job Responsibilities:**



+ Perform basic to complex activities in seed train, fermenter operation, harvest/clarification, and purification of plasmid DNA in a clinical/commercial cGMP environment.

+ Demonstrate knowledge of upstream and downstream unit operations equipment and processes.?

+ Assist in development and implementation of cGMP procedures and policies related to Manufacturing Operations.

+ Documentation of all activities in Batch Records, Logbooks, Forms, etc. and electronic interfaces.

+ Prepare for production by reviewing manufacturing schedule; studying and clarifying specifications; calculating requirements; assembling single use consumables and prepare needed materials and supplies.

+ Provide written and verbal updates to supervisors or other senior staff.

+ Maintain the highest standards of workplace Safety and product quality.

+ Follows verbal and written procedures in operating manufacturing equipment and performing processing steps; accurately completes appropriate production documentation.

+ Identifies, escalates, and documents events and deviations and subtle variances that deviate from normal operation; participate as needed in investigations and process improvements.

+ Work in accordance with regulations, detailed protocols, Batch Records, SOPs, and Work Instructions.

+ Maintain production facilities at a high standard of cleanliness, organization, complete and review GMP documentation in a timely manner to meet batch disposition commitments.

+ Maintain appropriate level of training for assigned responsibilities.

+ Oversee installation, commission, and troubleshooting equipment as needed.

+ Conducts training for less experienced personnel.

+ Interface with manufacturing support groups to align on production requirements.

+ Provide Leadership

+ Use strong communication and teamwork skills to build relationships across the manufacturing site.

+ Demonstrate technical acumen, operational understanding, and cGMP compliance in managing the manufacturing operations.

+ Support operational excellence initiatives, and the implementation of new technologies and systems.

+ Ensure a strong culture in safety and GMP compliance.


**Minimum Qualifications:**



+ High School Diploma or Equivalent (required)

+ Over 1 year of industry related experience.


**Preferred Qualifications:**


+ Strong verbal and written communication skills

+ Knowledge of Good Documentation Practices

+ Experience with ISO 9001, ISO 13485 and/or GMP manufacturing environment

+ Working knowledge of Microsoft based software such as MS Word and Excel.

+ Bachelors Degree in Life Sciences, Engineering, or Biotechnology or certificate program and two to four years biotech or pharmaceutical related experience.


**Knowledge, Skills Abilities:**



+ Strong interpersonal and communications skills: written and oral

+ Self-starter

+ Solid understanding of applicable regulatory requirements

+ Strong working knowledge of MS Office

+ Ability to deliver high quality documentation paying attention to detail

+ Regularly required to lift up to 25 pounds. May be required to lift weight of 50 pounds or more, with assistance and/ or with equipment on occasion.


**What happens next**

Once you apply, youll proceed to next steps if your skills and experience look like a good fit. But dont worryeven if this position doesnt work out, youre still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.


Helping you discover whats next in your career is what were all about, so lets get to work. Apply to be a Lead Operator today!


**\#VN2022**


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


Youre looking to keep your career moving onward and upward, and were here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.


**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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-05-02 Expires: 2022-06-02

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Lead Operator - Days

Kelly Services
Carlsbad, CA 92008

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