Job Description:

Description

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Manufacturing Specialist,

San Jose, CA

Your Tasks:

As a member of the Miltenyi Biotec team, you will ensure proper documentation and response to all manufacturing-related quality events, business process ownership, process improvement initiatives, tracking and trending operational performance, and training. Additionally, you will provide subject matter expertise and technical support to the manufacture of biologics under cGMP conditions. As a result of your ability to drive process improvement initiatives using lean principles to support the management of performance management metrics, you will support the continued success of Miltenyi Biotec as a whole.

Among other responsibilities, you will:

• Oversee the initiation and timely completion of Manufacturing related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Requests.


• Coordinate the development, writing, and review of Standard Operating Procedures (SOPs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation Performs manufacturing review of logbooks and executed records.


• Participate in internal and external audits as a manufacturing Subject Matter Expert (SME) Adheres to clean room Standard Operational Procedures (SOPs) for gowning, traffic flows, modes of operation.


• Provide technical and operational leadership, assists Department head to ensure on time execution of operations; may provide day-to-day supervision to junior staff.


• Troubleshoot processing issues, investigate in detail and establishing root cause and resolution/corrective action.


• Support validation activities as needed.


• Help to train the junior staff as needed.

Requirements:

• Bachelor's Degree from a four year college or university and at least 2 years of related experience in a GMP or research manufacturing environment; or equivalent combination of education and experience.

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 25 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:

This job is performed in a temperature controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, 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 such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

Miltenyi Biotec is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

We empower great science. For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 3,000 scientists, engineers, physicians, support specialists, marketers and more - all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

Miltenyi Biotec North America is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity