Our leading Biotech client is seeking a Quality Control Microbiology Engineer II (Monday-Friday, 1st Shift) who will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin and will support two sites in Allendale, NJ to include clinical and commercial production. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer II will include but are not limited to: 

Microbiological Testing:

• Growth Promotion
• Microbial Identification
• Sterility Testing
• Gram Stain
• Endotoxin

Equipment monitoring:

• Ensure equipment is in proper working conditions
• Ensure all equipment is properly maintained/calibrated
• Shipping of test samples and equipment to contract laboratories for testing
• Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Writing/conducting investigations pertaining to microbiological testing
• Develop and train QC Microbiology Engineer I personnel on relevant business processes 

REQUIREMENTS 

• BA/BS in a science or relevant field required or equivalent experience
• 2-4+ years of experience with microbiological testing or within the biopharmaceutical industry.
• Proficient with computer software such as
• Microsoft Office
• MODA/LIMS
• Familiarity with ISO and EU standards
• Strong written and oral communication skills
• Technical writing skills
• Technical training ability
• Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities 

While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. 

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey.