Quality Assurance Validation Senior Specialist

Quality Assurance Validation Senior Specialist
Sunnyvale, CA

Your Tasks
As a member of the Miltenyi Biotec Quality Assurance and Compliance team, you will have the exciting opportunity to provide quality oversight to validation and engineering activities. You will be responsible for ensuring compliance with all relevant FDA and EU regulations and guidelines throughout the product life cycle. Furthermore, you will review and approve validation procedures, protocols and reports, IQ/OQ/PQ packages and all engineering related documents. Overall, your exceptional technical ability and understanding of validation will champion the continued development of Miltenyi Biotec products and growing success.

Requirements
• B.S. degree in the life sciences from a four-year college or university; or equivalent combination of education and experience
• A minimum of 5 years' progressive experience in a cGMP environment and 2 years' experience in an engineering, validation or quality assurance role in a biotechnology or pharmaceutical environment
• Must have experience with aseptic processing
• Must be authorized to work in the U.S.

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch.  The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.  Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. 

Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.

Miltenyi Biotec is a company that is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

At Miltenyi Biotec Inc., we have developed state of the art manufacturing processes for innovative cellular therapies. We are scientists, engineers, physicians, support specialists, and more – all dedicated to improving scientific understanding and impacting human lives. At our Sunnyvale facility we strive to find solutions to both the technical and conceptual barriers to enable development of cell and gene therapy approaches for the treatment of human disease.

Miltenyi Biotec, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity