Jobs search

Environmental Monitoring Specialist II (1st Shift)

Immatics US • Full-time • Houston, Texas • 1m ago

FLSA Classification: Non-Exempt/Hourly

Schedule:Monday – Friday; 8:00 am – 5:00 pm; Occasional off-shift hours, weekends and holidays when needed

Department:Global Quality Operations

Reports to: Associate Director, Microbiology Quality Control

Supervisory responsibilities: No

Location:13203 Murphy Rd. Stafford, TX 77477; Fully On-Site

Position Summary/objective:

The main role of the Quality Control Specialist II, 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.

Secondary functions:

Assist with equipment and assay qualifications

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 public roads between sites in the Houston area.

This position regularly works 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 (degree may be waived for more years of experience)

Minimum two (2) years experience in a laboratory and cleanroom environment

Preferred education and experience:

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

Laboratory skills including more than one of the following: microscopy, visual inspection, cell count & viability, sterility, endotoxin, and mycoplasma

Experience in environmental monitoring performance and qualification for drug product production.

Experience writing GxP deviations, environmental excursion reports, OOS/OOE, CAPAs, change controls, etc.

Additional eligibility requirements:

Must have dependable transportation to travel between sites.

Work authorization/security clearance requirements:

Legal eligibility to work in the United States is . Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment

Affirmative Action/EEO statement:

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medicalconditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.”

Other duties:

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.This job description may not cover all duties that take place on a daily basis and may be changed as business needs change.Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.