Manufacturing Technician Assistant
Manufacturing Technician Assistant
Manufacturing of cell therapy products.
Responsible for the execution of activities supporting the manufacture of commercial cell therapy products meeting internal and regulatory requirements.
- Perform procedures supporting manufacturing in classified areas (e.g., ISO Class 7 and ISO Class 8 cleanrooms) in accordance to established SOPs, cGMPs, and safety regulations.
- Removal of Sharp containers and disposal of liquid Biohazard waste from classified areas.
- Operation of manufacturing support equipment (e.g., glass washer, depyrogenation oven, autoclave, heat sealer, etc.).
- Assist with packaging clean and sterilized material.
- Restock and distribute material into classified areas in accordance with specific material requirements (e.g., sterilized manufacturing instruments, etc.)
- Maintain vacuum traps and water baths in clean room manufacturing suite(s).
- Perform clean room equipment sanitization (e.g., daily, weekly, etc.).
- Perform general housekeeping of controlled manufacturing areas.
- Collect and submit manufactured samples for QC testing.
- Document activities in corresponding batch records and log sheets according to cGMPs and established SOPs.
- May record equipment metrology readings to ensure the equipment operates within specifications.
- May perform aseptic manipulations of cell culture processes and final product assemblies.
- May assist and participate in scheduled physical inventory activities.
- May assist in providing on the job training to employees.
- Work independently under general supervision and direction.
- Practice safe work habits and adhere to Vericel’s safety procedures and guidelines.
- Other duties as assigned.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- GED, High school diploma or equivalent with 0 - 2 years of experience working in a cGMP environment in the biotech or pharmaceutical industry
- Familiarity with MS Office (e.g., Outlook, Word, etc.).
- Will consider relevant experience in lieu of education.
- Experience working in ISO 7 and 8 cleanroom environments
- Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
- Excellent communication skills, written and verbal.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Ability to gown and gain entry to manufacturing areas.
- May be required to stand for long periods of time while performing physical duties.
- May be required to sit for long periods of time while performing cell culture operations.
- Must be able to lift, carry, push and pull up to 50 lbs.
- Ability to work 1 weekend day.
- Rotating holiday coverage.
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.