Quality Engineer - CARR Biosystems
- Employer
- CARR Biosystems
- Location
- Clearwater, FL
- Start date
- Aug 9, 2022
View more
- Discipline
- Engineering, Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
About Us:
As a member of the Barry-Wehmiller family of companies, CARR Centritech has been an industry leader in centrifugation for more than three decades. Today, CARR Biosystems continues that pioneering legacy by delivering high-performance, fully-scalable bioprocessing solutions to accelerate process development. Our mission is to advance life-saving and life-enhancing solutions worldwide by supplying the best bioprocessing equipment on the market. In the process, we empower scientists and engineers to produce vital biologics in emerging and established markets, including cell and gene therapy, vaccine development, microbial fermentation and cellular agriculture. For more, visit carrbiosystems.com.
Job Description:
CARR Biosystems has an opening for a quality engineer. CARR Biosystems is a rapidly growing business unit that has developed a line of single use centrifuges that can address bioreactor volumes from 4 L to 2000 L. Joining Carr Biosystems, you will be a part of a dynamic team that will support and enable the use of this technology to create life-saving treatments in through bioprocessing.
Job Responsibilities
- CAPA Process including
- Correspondence with customers
- Correspondence with subcontractors
- Root cause analysis
- Report writing
- Implement change control in the process
- Work with engineering to develop new techniques for single use manufacturing
- Trouble shoot new and existing processes including hands-on testing
- Development, maintenance and interpretation of KPI’s
- Write or update SOP’s based on current manufacturing practices
- Obtain feedback and approvals for key stakeholders
- Train others in the final cGMP/ISO documents.
- Work with subcontractors to:
- Identify and implement corrective actions
- Drive corrective actions to completion
- Trouble shoot manufacturing issues
Preferred Skills
- Experience with mechanical design & drawing proficiency
- Knowledge of Materials: Engineering plastics, injection molded polymers, stainless steel, aluminum alloys
- Experience in biotech product Mfg. & bioprocesses
- Familiarity of designing for ISO, USP, ICH biopharm device validation compliance
- Understand concepts in injection molded plastics, Mfg., production, inspection
- Have experience with statistical problem solving methods such as: Ishikawa, FMEA, DOE, Pareto chart, Histogram with Cpk
- Understand Machine Design, Fluid Dynamics, Heat Transfer, Vibrations, Thermodynamics Theory, Fluid control Pneumatic electro/mechanical assemblies
- Be able to interpret P&ID functional and electro/mechanical drawings
Requirments
- Minimum 5 years experience
- Experience using Solidworks or other 3D drafting program
- Experience with cGMP and/or ISO compliant quality system
Education
- Minimum BS Engineering
At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Company:
PneumaticScaleAngelusGet job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert