Manufacturing Technician BioProcess
1000 New Horizons Way, VAC09 Vacaville, CA 95688
Bayside Solutions is seeking a Manufacturing Bioprocess Technician to be part of our client’ s team in Vacaville. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Manufacturing Bioprocess Technician
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- As a Manufacturing Technician, you will be responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in a current Good Manufacturing Practices (cGMP) environment. You will maintain areas in a high state of inspection preparedness and will utilize business systems for inventory and process management. You will maintain records to comply with regulatory requirements utilizing cGMP and Standard Operating Procedures (SOPs) and will participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:
- Upstream Manufacturing (UM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations; perform seed train operations; perform dispensing of components; handle and aliquot hazardous materials.
- Downstream Manufacturing (DM):? Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems; perform dispensing of components; handle and aliquot hazardous materials.
- Production Services (PS): Provide support to Manufacturing to meet production demands. Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean and Kanban, glassware, parts and equipment; perform weighing and kitting of components; handle and aliquot hazardous materials; provide quality materials and service to our customers.
- Follow established safety and environmental guidelines and procedures for all work performed
- Immediately report safety and environmental incidents, including injuries, illnesses, near misses, and safety suggestions
- Foster safe work practices
- Operate systems that clean and sterilize tanks and filtration systems
- Prepare materials for the production process
- Exhibit detail oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)
- Escalate process issues as necessary to ensure resolution of issue
- Comply with cGMP, SOP and manufacturing documentation
- Use automation to perform production and equipment operations
- Provide support to Manufacturing to meet production demands
- Assemble and prepare equipment for production
- Communicate effectively and professionally work in a team environment
Summary of Qualifications:
- Required: High School Diploma
- Desirable but not required: AS/BS/BA in Biological Sciences, Physical Sciences, or Engineering or combination of
- College coursework and related work experience or Biotech certificate from approved program
- Strong oral and written communication skills
- Familiarity of computer-based systems
- Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job
- Ability to read and understand engineering documents is desirable
- Experience in creation and revision of SOPs and Manufacturing Formula is desirable
- Must be able to work weekends, off-shifts, and overtime as required
- No make-up or jewelry can be worn when working in the clean room environment
- Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam, water, air and cleaning/sanitizing chemicals systems
- Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift
- Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift
- Handle and work with hazardous materials and chemicals per OSHA guidelines
- Usage of hearing protection and dust masks may be required
- Expected to be on feet standing or walking for up to 90% of shift
- Travel up to 30 flights of stairs each shift to maneuver within the facility
- Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems
- Lift up to 40lb (18.2kg) loads multiple times per shift and carry up to 30 lbs(13.6kg). Team lifting will be used for heavier or awkward lifts/carries up to 20 times per shift.
- Push or pull materials with up to 50lb-force with full body. Utilize mechanical means or powered industrial trucks for forces beyond the 50lb-force limit up to 10 times per shift.
- Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces must be exerted. Forces should not exceed 22 pounds/inch2 (10 kg/cm2).
- In order to operate powered industrial trucks, employee must pass a DOT Physical which includes: Blood Pressure < 140/90, Vision must be at least 20/40 in both eyes with or without corrective lenses, pass color vision and whisper hearing test as well as have a valid Driver’ s License.