Senior Environmental Monitoring Specialist - 2nd Shift (1004)

FLSA Classification: Exempt/Salary 

Schedule: Monday – Friday; 1230 – 2100; Occasional off-shift hours and weekend or holiday shifts as required; Fully On-Site. 

Department: Global Quality Operations 

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 Senior Quality Control Specialist Environmental Monitoring is to provide daily support to the Environmental Team and daily operational environmental monitoring 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). 

• Execute and provide support for the schedule of the safety testing program and environmental monitoring of aseptic production areas. 

• Perform microbial trending of personnel and aseptic production areas and guide the environmental excursion program for excursion investigations. 

• Author study plans and perform sterility, endotoxin, and mycoplasma matrix verifications as per USP and EP guidelines, writing and review of SOPs, and other documentation under cGMP environments. 

• Support aseptic media fill process simulations. 

• Responsible for QC micro equipment validation, maintenance, and calibration. 

• Other relatable functions may be determined. 

Secondary functions: 

• Train junior analysts. 

• Assist with group tasks scheduling. 

 Competencies:  

• Works independently. 

• Capable of aseptic gowning. 

• Strong communicator and 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 lab environment with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. Other duties performed while outside of office and lab building could involve exposure to manufacturing operations, along with outdoor conditions (including highway traffic) and temperatures. 

• While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, fumes or airborne particles, pathogens, and toxic or caustic chemicals. The employee can be occasionally exposed to wet and/or humid conditions, risk of electrical shock, sharps, or cuts, while performing tests. This position requires handling of human biological specimens including human peripheral blood and human T cell products, as well as laboratory chemicals. 

• This position requires local travel in personal vehicle on the