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Woodstock Sterile Solutions is the leading North American blow-fill-seal (BFS) sterile contract development and manufacturing organization (CDMO).  From our 430,000 sq. ft. advanced aseptic manufacturing facility in Woodstock, Illinois, we leverage 50+ years of BFS technology leadership and our patented cold BFS process to serve clients from clinical development through commercial scale. We are committed to Proven Excellence. Trusted Solutions.

Position Overview

The Microbiologist I is responsible for performing microbiological analyses, in-process bioburden testing, and final product endotoxin and sterility testing supporting our sterile BFS manufacturing operations.  This position will be scheduled for Tuesday - Saturday, 8:00AM - 4:30PM.

Key Responsibilities

Foundational Duties:

• Completely, accurately, and precisely prepare all laboratory reports and/or test scripts and documents in accordance with cGDP and cGMP requirements

• Demonstrate high ethical standards and maintain current training status on relevant equipment and procedures

• Comply with all cGMP, regulatory, corporate, and EHS requirements

• Maintain the laboratory in audit readiness per cGDP and cGMP practices

• Perform peer review for testing and calculations as necessary; recognize and escalate Out of Specification, atypical, and/or anomalous data to management

Laboratory Work:

• Maintain, clean, and sterilize laboratory instruments and equipment

• Perform water sampling, including DI water, WFI, and steam

• Perform sterility, endotoxin, and bioburden testing of product and microbiological samples

• Subculture and characterize microbial isolates using Gram stain

• Perform growth promotion testing of liquid and plated media, including media fills

• Perform bacteriostasis/fungistasis testing to validate test methods

• Process and incubate exposed biological indicators; receive and prepare samples and equipment for testing

• Incubate and examine tests, including bioburden, sterility, biological indicators, and media fill units

• Enumerate bacteria and prepare shipments for outside laboratories

• Clearly communicate testing requirements and expectations; understand environmental monitoring, testing requirements, and result interpretation

• Operate and maintain laboratory equipment, including incubators, autoclaves, ovens, and vacuum pumps; assist with qualifications and validations

• Support R&D and Technical Services activities

• Maintain effectiveness of Quality System components relevant to this position; identify, evaluate, and manage risk to ensure product quality

• Perform other duties as assigned

Qualifications

Education: B.S. in Microbiology, Biological Sciences, or equivalent required.

Experience: Experience in a laboratory setting (academic, internship, or other) required.

Knowledge & Skills:

• Demonstrated intermediate mathematical ability

• High level of attention to detail; well organized and multi-task oriented

• Excellent documentation skills and strong written/oral communication skills

• Strong problem-solving and analytical skills

• Works well in a team environment with a variety of individuals and personalities across departments

• Proactive, able to multitask, and willing to take initiative and responsibility

• Familiarity with cGMP and safe work practices

• Sound judgment and ethical conduct

• Demonstrated ability to read, write, and speak clear English

Physical Requirements

• Ability to stand for up to 8 hours per day; visual acuity of 20/30 corrected vision

• May be exposed to inclement weather or conditions requiring protective gear and awareness of personal safety

• Frequent sitting, standing, walking, climbing ladders/steps, reading written documents, and use of a computer monitor screen; reaching, twisting, writing, talking, bending, handling, turning, balancing, carrying, grasping, and listening

• Occasional walking on inclines/uneven terrain, stooping, kneeling, and crouching

• Frequent lifting and/or moving up to 20 pounds and occasional lifting/moving up to 30 pounds

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.