Manufacturing Specialist *PC 555

San Jose, CA 2825 N First Street San Jose, CA 95134, USA This position is responsible for a variety of activities supporting the Manufacturing Operation. The responsibilities include but not limited to the following: ensuring proper documentation and response to all manufacturing-related quality events, business process ownership, process improvement initiatives, tracking and trending operational performance, and training. In addition, this position will provide subject matter expertise and technical support to the manufacture of biologics under cGMP conditions. Essential Duties and Responsibilities: Perform on the floor duties as needed. 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. Provide technical leadership. Troubleshoot processing issues, investigating in detail and establishing root cause and resolution/corrective action. Support validation activities as needed. Help to train the junior staff as needed. Drive Process Improvement initiatives using Lean Principles Supports the management of performance management metrics. Other Manufacturing activities to assure successful operations. Requirements: Bachelor's Degree from a four-year college or university; At least 2 years of related experience in a GMP or research manufacturing environment. 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. 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. The hiring range for this position is expected to fall between $80,591 - $94,903/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications. The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions. Miltenyi Biotec, Inc is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity Miltenyi Biotec, Inc. participates in E-Verify. The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr Miltenyi Biotec, Inc.