Environmental Monitoring Technician

Cellipont Bioservices•The Woodlands, TX

About The Position

Cellipont Bioservices, operating as Kincellis Advanced Therapies, is seeking an Environmental Monitoring Technician to support its Quality Control department. The role is responsible for sampling, analyzing, and reporting environmental monitoring results in support of manufacturing biologic bulk drug substance, sterile finished drug product, and fill/finish in a fast-paced contract manufacturing and development organization (CMDO) environment. The technician performs routine monitoring in Grade A-D cleanrooms, assists with cleanroom performance qualifications and sample enumeration, and supports gowning qualifications and aseptic process simulations. The role requires accurate GDP-compliant documentation, collaboration with manufacturing, Quality Assurance, and QC Microbiology, and adherence to GMP, safety, and gowning procedures. The position works second shift, Monday through Friday, with occasional weekend or holiday support as needed. The company describes opportunities for career growth, mentorship, and experience in cell therapy.

Requirements

  • High school diploma or equivalent.
  • 0–1 year of experience in an environmental monitoring or cleanroom setting; ideally in biotech, pharmaceutical, or cell/gene therapy industries.
  • Knowledge of and ability to apply basic scientific and regulatory principles to operational and routine quality tasks.
  • Ability to follow standard operating procedures (SOPs) and document activities accurately and promptly.
  • Comfort working in a highly controlled cleanroom environment for extended periods.
  • Availability to work second shift (2:00 PM–11:00 PM), Monday through Friday, with occasional weekend or holiday support as needed.

Nice To Haves

  • Associate's or Bachelor's degree in Microbiology, Biology, or a related field.
  • Environmental monitoring or cleanroom experience in the biotech, pharmaceutical, or cell/gene therapy industries.

Responsibilities

  • Perform routine Environmental Monitoring in Grade A-D cleanrooms, including viable surface, viable air, and non-viable particulate sampling.
  • Perform and assist with Environmental Monitoring Performance Qualifications (EMPQ) of cleanrooms.
  • Perform and assist with EM sample enumerations.
  • Accurately document sampling activities in compliance with Good Documentation Practices (GDP).
  • Support gowning qualifications and aseptic process simulations (media fills).
  • Respond to deviations and alert/action limit excursions, and perform preliminary investigations.
  • Prepare and transport samples to the microbiology laboratory for incubation and analysis.
  • Collaborate with manufacturing, Quality Assurance, and QC Microbiology teams to ensure compliance with GMP regulations.
  • Assist with data trending and routine Environmental Monitoring reporting.
  • Follow safety and gowning procedures within classified cleanroom areas.
  • Perform other duties as assigned.

Benefits

  • Opportunities for career growth within an expanding team.
  • Defined career path and annual performance review and feedback process.
  • Cross-functional exposure to other areas of the organization.
  • Robust benefits package designed for health and wellness needs, including coverage for pets.
  • 401(k) with strong employer match.
  • Tuition reimbursement.
  • Employee referral bonuses.
  • Flexible work schedules.
  • Paid time off and paid holidays.
  • Mentorship and experience in the cell therapy field.
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