microbiologist.

Responsibilities:
Perform a variety of routine microbiological assays on in-process, finished product, and raw material samples, including but not limited to Endotoxin, Sterility, and Bioburden testing.
Conduct rapid microbiological methods, such as Mycoplasma detection (qPCR), according to established Standard Operating Procedures (SOPs).
Perform microbial identification (ID) and characterization of isolates using methods such as Gram staining.
Execute comprehensive Environmental Monitoring (EM) within controlled and cleanroom environments (ISO 8 to ISO 5), including viable air, non-viable air, and surface contact sampling.
Collect and test utility samples, such as Water for Injection (WFI), RODI water, and compressed/process gases.
Enumerate, report, and trend microbial colony counts from EM and utility samples.
Maintain detailed and accurate laboratory records, ensuring compliance with cGMP/GLP and data integrity principles (ALCOA++).
Participate in laboratory investigations, deviations, and Out-of-Specification (OOS) results, conducting root cause analysis for environmental excursions.
Draft, revise, and review SOPs, protocols, technical reports, and batch documentation related to QC Microbiology.
Maintain and clean the QC laboratory, manage inventory, and perform media growth promotion and sterilization checks (autoclave operation).
Collaborate effectively with Quality Assurance, Manufacturing, and Process Development teams to support product release and contamination control strategies.

Working hours: 8:00 AM - 5:00 PM

Skills:
Industry Experience: 3+ years of direct experience in a GMP/GLP Quality Control Microbiology laboratory, preferably within the Biotechnology, Cell and Gene Therapy, or Pharmaceutical industry.
Experience with Environmental Monitoring programs in a cleanroom manufacturing setting.
Practical experience with qPCR (quantitative Polymerase Chain Reaction) for Mycoplasma or other assays.
Familiarity with microbial identification systems (e.g., MALDI-TOF, MicroSeq).
Systems: Experience utilizing a Laboratory Information Management System (LIMS).
Problem-Solving: Proven ability to troubleshoot laboratory issues and participate in deviation/investigation processes.

Education:
Bachelors

Experience:
1-4 years

Qualifications:
Bachelor's degree in Microbiology, Biology, Biochemistry, or a closely related scientific field.
Demonstrated proficiency in aseptic technique and conducting microbiological testing (e.g., sterility, bioburden, endotoxin).
Foundational understanding of cGMP (current Good Manufacturing Practices) and regulatory requirements (FDA, EMA) applicable to biopharmaceutical manufacturing.
Strong attention to detail, exceptional organizational skills, and the ability to accurately analyze and interpret raw data.
Excellent written and verbal communication skills for documentation, report writing, and cross-functional teamwork.


Apply today!

Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.

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At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).