The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives.

• Microbiologist II is an integral part of the team, performing various microbiological testing for finished products, raw materials, stability, etc.
• Perform environmental monitoring and utility testing of the facility.
• Participate in investigations of OOS results and other related studies.
• Participate in validation, troubleshooting various types of equipment including proactive resolution of instrument issues.
• Investigate and suggest new laboratory procedures/techniques.
• Validate and implement new laboratory procedures/techniques.
• Monitor all physiological and morphological characteristics and identify microorganisms.
• Maintain accurate records and perform tests on all activities conducted in the laboratory.
• Develop and document various microbiology laboratory processes and prepare final reports.
• Perform Compressed Air and Compressed Gas sampling to support manufacturing and/or qualification activities.
• Perform Viable Air, Total Particulate Air (Non-Viable), Surface (RODAC), and Swab sampling to support manufacturing and/or qualification activities.
• Perform Standard Operating Procedure (SOP) revisions.
• Perform Microbiological Deviation Investigations, Corrective and Preventative Actions (CAPAs), and Change Requests (CRs).
• Reviews and/or writes technical reports, procedures, and protocols.
• Draws conclusions from data and communicates those conclusions is writing.
• May Schedule laboratory testing and associated activities to minimize operational disruptions to departments.
• May manage inter-departmental projects to ensure timely completion of objectives.
• Completes any other duties assigned by QC management as required.

Competencies:

Education / Experience:

• Minimum of four years of experience in the Pharmaceutical or Biotechnology industry with a bachelor’s degree in Microbiology, Biology or related scientific field required. Alternately, three to six years of experience with a master’s degree in Microbiology or related scientific field. Alternately, zero to three years of experience with a PhD in Microbiology or related scientific field -Required.
• Candidate must have broad knowledge in all types of microbiological compendia testing (USP, EP, JP, BP) -Required.
• Good written English and verbal communication skills-Required.
• Must be highly organized and able to work under pressure.
• Must have strong interpersonal and leadership skills.
• Must be computer literate with knowledge in all Microsoft business applications.

Judgment / Decision Making:

Duties are performed under general direction toward broad assignments with periodic reviews. Duties are performed within the framework of departmental or functional guidelines, requiring interpretation and original thinking.

Work Environment:

A laboratory environment with exposure to microorganisms, safety cabinets, heat, and electrical current.

Physical Demands:         

Visual acuity and manual dexterity required to operate computer, analytical instrumentation, sample preparation and proofread documents. The majority of time is spent sitting and walking. Often required to lift objects weighing up to 20 pounds.