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in San Diego, CA

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Hours Full-time, Part-time
Location San Diego, CA 92121
San Diego, California

About this job

Manufacturing / Production Technician - Aseptic Fill exp., San Diego, CA Job Summary: The responsibilities for this position include, but are not limited to, the manufacturing of collagen/PMMA product in a FDA regulated aseptic and non-aseptic clean room environment (Class 100 to 10,000) in accordance with cGMP's (current Good Manufacturing Practices) and other applicable regulatory requirements, such as ISO and OSHA.  Essential Duties and Responsibilities:  Follow written SOPs and batch records for lean manufacturing and aseptic filling of final product, which includes inspection, labeling, and final product packaging.  Record process operations and data calculation entries into batch records.   Qualify for aseptic gowning and operations (syringe filling) on a semiannual basis.  Manually fill syringes in an aseptic environment for extended durations while being monitored for viable and non-viable microbial growth.  Perform line clearance prior to the commencement of each process by ensuring the all related materials / components are released for use, and non-related materials / components are not present; therefore removed.  Process raw bovine in preparation for collagen extraction and purification. Assemble pressure and vacuum tanks and process equipment. Formulate acidic and caustic dilutions from concentrated stock solutions. Process and sieve PMMA microspheres. Print and inspect controlled labels for final product packaging. Perform 100 percent inspection of product syringes (skin test and PMMA/collagen). Clean and sterilize (autoclave) process equipment, vessels, and cleaning equipment.   Clean non-aseptic and aseptic areas (ceilings, walls, floor, and biosafety cabinets).  Neutralize waste using acidic or caustic solutions before discarding. Participate and support implementation of changes in processes and policies to maintain high professional standards. Fill voids within the production operation, as required. Demonstrates an acceptable level of proficiency     Performs other work related duties as assigned. Maintain compliance with all Quality Systems requirements. Fully adhere to all applicable FDA regulations, international guidelines and company policies at all times. Job Requirements:  High School Diploma or equivalent. Minimum four (4) years Biotech / Pharmaceutical manufacturing and cGMP experience  Experience or knowledge of Kaizen manufacturing principles (JIT, 5S)  Prior experience with aseptic processing, collagen manufacturing is preferred. Experience with assembly, equipment sanitation, and clean room practices is required.  Experience in an aseptic clean room class 100 environment is preferred. Experience with Process Controls and Documentation practices in an ISO / FDA Regulated Environment. Familiar with terminology used in the procedures, rules and regulations governing medical device Ability to work effectively under fully gowned clean room conditions for extended periods of time. Display a strong focus on safety, quality, detail, and results.  Solid working knowledge of Lean Manufacturing principals within a cGMP facility. Strong laboratory and wet chemistry experience. Mechanical aptitude, basic problem solving skills, and a familiarity with computer-based systems. Good communication skills, both written and verbal Ability to organize and prioritize work to meet deadlines Good interpersonal skills Occasionally the employee will be required to lift or move at least 50 pounds. Ability to work overtime and weekends are required on an as needed basis. Apply Today!  Questions?  Call Carl at 858.207.6311 Why Kelly®? With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today. About Kelly Services® As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter. Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.]]