Microbiologist I (Tuesday - Saturday

Microbiologist I (Tuesday
- Saturday)

Full Time Woodstock, IL, US

Salary: $55,000.00 Annually

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.

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.

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 escalation 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/fungi stasis 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

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

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