Environmental Monitoring Specialist II

FLSA Classification: Non-exempt/Hourly 

Schedule: Monday – Friday; 12:30 pm – 9:00 pm (Second Shift), On-Site 

Department: Quality Control 

Reports to: Associate Director, Microbiology Quality Control 

Supervisory responsibilities: No 

Location: 13203 Murphy Rd. Suite 100 Stafford, TX 77477

Position Summary/objective: 

The main role of the Quality Control Specialist Environmental Monitoring is to provide daily operational support and environmental monitoring (EM) services to the Immatics aseptic production areas and perform/provide safety testing for final drug product release. 

Essential functions: 

• Perform EM of the classified aseptic production areas including incubation of samples, reading of results, reporting, and approving data (EM activities include but are not limited to contact plates, viable/non-viable counts, microbial ID testing/send-outs, and operator monitoring) 

• Conducts microbiological media growth promotion and maintains department stock cultures. 

• Supporting aseptic media fill process simulation validations. 

• Responsible for QC micro equipment validation, maintenance and calibration 

• Performs safety testing on in-process and final drug products 

• General laboratory operations (ordering supplies and culture media, operating laboratory equipment, sample receipt, and send outs) 

• Other relatable functions may be determined. 

Competencies 

• Works independently 

• Capable of aseptic gowning 

• Collaborates effectively with coworkers and between departments 

• Flexible and able to work under pressure and meet project timelines 

• Able to perform duties within a GMP aseptic cleanroom. 

 Work environment: 

 This position works in a typical office and/or clinical lab environment with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, pathogens and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions, risk of electrical shock, sharps, or cuts, while performing tests. Second shift work/ support from 12:30 pm to 9:00 pm to support GMP operations. Occasional weekend work/support may be required to support GMP operations. 

Physical demands: 

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.  

• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.  

• Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.   

• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder.  

• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).   

• Pushing - Exerting force upon an object so that the object moves away from the object.  

• Pulling - Exerting force upon an object so that the object moves toward the force.   

• Sitting – remaining in a sitting position for at least 50% of the time.  

• Standing/Walking - remain on one's feet in an upright position at a workstation.   

• Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.  

Travel required: 

• Less than 10%, minimal 

 Required education and experience 

• BS in a science related field, preferably in Microbiology (degree may be waived for more years of experience) 

• Two (2) or more years’ experience working in a pharmaceutical/biopharmaceutical ISO 5 environment 

• Experience with aseptic process simulation is a plus 

Preferred education and experience 

• Three (3) or more years’ experience working in a pharmaceutical/biopharmaceutical ISO 5 environment 

• Experience using a BacT/ALERT® 3D Dual temperature rapid sterility platform, Endosafe® rapid endotoxin platform, and BioFire® film array rapid mycoplasma platform is preferred. 

Work authorization/security clearance requirements