Technician I - Microbiology

About the role

Candidates in this role are responsible for the accurate and efficient execution of microbiological tests including aseptic processing of sterility tests in a cleanroom suite, particulate matter testing via the use of a laser particle analyzer or microscopic examination, endotoxin testing, or other microbiology pharmaceutical testing in accordance with established procedures.

Candidates will collect and present data in a well-reasoned and accurate manner and maintain the laboratory environment according to cGMP guidelines.

Responsibilities

• Preparing and performing microbiological tests on medical devices and pharmaceuticals as recommended by current USP, FDA, and AAMI/ISO regulations.
• Routine Quality Control of laboratory equipment, media, and microorganisms.
• Provide accurate test results to customers on a timely basis including but not limited to Bioburden, Limulus amoebocyte lysate (LAL) Sterility for Medical Devices, Off-Site Clean Room Validation and Monitoring, etc.
• Record test results accurately and legibly on all documents.
• Technical report writing including text, tables, graphs, and diagrams.
• Assist in the training of new Laboratory Technicians.
• Follow and perform process qualifications and validations for procedures and/or equipment.
• Maintain control of test samples including logging in, storage, tracking, and disposal.
• Monitor test status and conditions as described in Work Instructions and Operating Procedures.
• Routine maintenance of laboratory environment to include cleaning and troubleshooting.
• Report any deviations and/or nonconformities to Management.
• Suggest possible preventative and corrective measures to prevent future deviations and nonconformities.
• Inventory of laboratory supplies to maintain par levels.
• Perform onsite and offsite testing.
• Gowning and garbing for cleanroom settings.
• In cooperation with the Laboratory Manager, responsible for the qualification, maintenance, and calibration of critical equipment.
• Update procedures for improvement to methods.
• Assist with OOS, NI, CAPA, and Change Control processes in response to Laboratory issues.
• Driving a company car for offsite work, if applicable.
• Other duties as assigned.

Qualifications

Education: Bachelor's degree in Microbiology or related life science.

Experience:

• Ideally 1-3 years of experience performing basic microbiological laboratory tests including but not limited to Bioburden, Limulus amoebocyte lysate (LAL) Sterility for Medical Devices, Off-Site Clean Room Validation and Monitoring, etc.
• 1 year of experience with GMP/ISO/USP, etc.

Competencies:

• A highly competent and proficient worker, capable of multi-tasking, being self-motivated, and taking initiative.
• Personal attributes should include honesty, integrity, adaptability, reliability, and positivity.
• Displays leadership skills, is able to train/teach others and possesses high-quality standards.
• Able to provide root cause analysis and corrective action for Out of Specification Results.
• Exhibits troubleshooting skills involving equipment-related issues.
• Maintains personal hygiene and cleanliness inside and outside the microbiology laboratory.
• Adherence to ISO/GMP/USP standards and completion of necessary training modules.
• Abilities in mathematical reasoning, arm-hand steadiness, finger dexterity, visual color differences, and deductive reasoning.
• Knowledge of laboratory equipment such as microscopes, velometers, balance, autoclaves, water purification systems, hood operation, particulate counter, membrane filtration, endotoxin plate reader, etc.
• Standard office equipment including computers, copiers, and scanners.
• Frequently requires the use of potentially hazardous chemicals and reagents.
• Must be able to lift up to 30 pounds.

Schedule

The position is full-time, Monday-Friday, 9:00am-5:00pm, with overtime as needed. Candidates living within a commutable range of Crown Point, IN are encouraged to apply.

Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.