Senior Microbiologist *PC 639

Your Tasks:

This position is responsible for planning, coordinating and facilitating microbial control activities required for products manufactured in San Jose MBI. The role will interact with all site and cross site functions that could impact San Jose's microbial control program including Facilities, QC Microbiology, Manufacturing, Process Development.

Essential Duties and Responsibilities:

• Responsible for the complete development, qualification and performance of environmental monitoring and microbiological QC assays to support GMP manufacturing operations in a multi-product CGT facility. Implement new microbiology related testing programs to support microbial control strategy, and support testing for EM/microbiology testing programs
• Provide support and oversight of the site's contamination control strategy. Provide microbiological support to audits and inspection readiness programs.
• Partner with Manufacturing to champion company's compliance to aseptic procedures and practices in accordance with current regulatory requirements and industry guidance. Engage directly with site personnel to promote an aseptic operations culture and to provide aseptic subject matter expert knowledge.
• Provide support for investigations pertaining to microbial contamination to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and determination and remediation plans. Provide support for tracking and implementation of corrective and preventative actions related to microbiology and aseptic operations.
• Support resolution of problems, identify trends and determine system improvements, communicate updates, metrics and outstanding items to senior personnel as required.
• Support the review and approval of microbial control related documents, including but not limited to, SOPs, validation and qualification documentation, protocols, reports and deviations/investigations, Change Controls.
• Mentor and develop Quality and Operations department staff, conducts training.
• Perform additional tasks as directed by senior management.

Requirements:

• Microbiology, Biology, Engineering or related discipline; Eight or more years of progressive experience in a biotechnology, or pharmaceutical industry with a GMP and/or ISO regulated environment; Or equivalent combination of education and experience.
• Experience in microbiology, sterilization, validation and environmental controls /cleanroom qualification, contamination control.
• Demonstrated competency in, endotoxin and sterility testing, and microbiological contamination, including alternative sterility test methods.
• Experience interacting with Regulatory Authorities.
• Experience with conducting technical assessments of in-house and external manufacturing with a proven track record on trouble-shooting microbiological, aseptic processing and/or sterilization process non-conformances and out of specification test results and providing resolution to issues via robust CAPA Required.
• High level knowledge of regulatory requirements and industry standards, including EU and ISO.

Skills:

• Strong organizational and time management skills, as well as a team player mindset with a customer focus.
• Excellent oral and written communication skills.
• Ability to communicate both up and down the business ladder within franchise or technical competency area is required.
• Capable of representing the corporation at customer and regulatory inspections required.
• Ability to communicate both up and down the business ladder within franchise or technical competency area is required.

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:

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 clean 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 exposed to viruses and bacteria. Employees entering 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 anticipated base salary range for San Jose, CA, has been established at $119,200 - $161,300 /year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company's good faith and reasonable estimate of the range 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, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of 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.