Environmental Monitoring Supervisor

FLSA Classification: Exempt/Salary 

Schedule: Monday – Friday; 1230 - 2100 

Department: Quality Control  

Reports to: Associate Director, Microbiology Quality Control 

Supervisory responsibilities: Yes 

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

Position Summary/objective: 

The main role of the Environmental Monitoring Supervisor is to provide oversight of Quality Control, Microbiology personnel who provide daily environmental monitoring services to the Immatics aseptic production areas and manage the day-to-day scheduling and activities within the Quality Control, Microbiology department. 

Essential functions: 

Management 

• Exemplify Best Practices: Guide others through their actions and serve as a positive influence for subordinate team members; leading by example, being a positive role model, perform consistent attendance with availability, illustrate integrity, and utilize transparent communication. 

• Training: Perform training of all new employees and ensure training status of each employee and ensure consistency of the environmental monitoring program. 

• Effective Hiring: Select team members who fit the job requirements, company culture, and team dynamics. 

• Organize and Manage: Efficiently manage team schedules, assignments, and workload distribution. 

• Frequent Communication: Ensure team members have the necessary information and tools through regular communication. 

• Support and Develop: Set goals, measure achievement progress, provide constructive feedback, resolve conflicts, and coach team members for growth and development. Recognize and give credit to team members – publicly and privately. 

Quality Control, Microbiology 

• Perform environmental monitoring of classified cleanrooms; surface sampling particulate monitoring, viable air monitoring, and personnel monitoring. 

• Incubate, track, read results, and report environmental monitoring samples. 

• Organize daily scheduling of environmental monitoring activities and ensure appropriate staffing. 

• Author, execute, and finalize study protocols for the support of the environmental monitoring program. 

• Author and lead quality documents; deviation reports, laboratory investigations, change controls, standard operating procedures, CAPAs, etc. 

• Review, organize, and submit final environmental monitoring documents to support drug product release. 

• Manage supply inventory, and equipment maintenance in collaboration with the department constituents. 

• Collaborate with adjacent departments for upcoming events and anticipate, schedule work tasks 

• Write, coordinate execution, and finalize environmental monitoring process qualifications. 

• Proficient in microbiological assays; sterility, microbial identifications, endotoxin, mycoplasma  

Competencies:  

• Demonstrate exceptional initiative and problem-solving skills, while ensuring a detail-oriented approach to every task. 

• Contain a strong analytical, technical writing, verbal communication, presentation, and interpersonal skills. 

• Ability to work independently and manage multiple projects with aggressive timelines. 

 Work environment: 

• This position works in a typical office and laboratory 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 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 condition, risk of electrical shock, sharps or cuts while performing tests. 

• This position requires the handling of human biological specimens including human peripheral blood and human T cell products, as well as laboratory chemicals. 

• This position can work in a cleanroom environment at level 3 gowning with moderate noise levels from HEPA filtration. 

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:  

• BA or BS in any science related field 

• Minimum of 5 years experience in a regulated laboratory environment 

 Preferred education and experience: 

• BA or BS in Biology, Biological Sciences, Microbiology, Biochemistry, or Biomedical Science/ Engineering. 

• Contain laboratory skills including microscopy, visual inspection, sterility, endotoxin, mycoplasma, and microbial identification. 

• Experience in environmental monitoring programs for the support of drug product manufacture. 

• Experience in writing assay qualifications, deviation reports, standard operational procedures, laboratory investigations, corrective actions and change controls. 

• Prior management of direct reports is preferred.