Environmental Monitoring Technician

Cellipont Bioservices • The Woodlands, TX

3d • Onsite

About The Position

Cellipont Bioservices operating as Kincellis Advanced Therapies is growing, and we are looking for an EM Technician, who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Kincellis and its clients to the next level. The Quality Control Environmental Technician is responsible for Environmental Monitoring sampling, analyzing, and reporting results, to support manufacturing. Works in a fast-paced environment supporting the quality control department of a CMDO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.

Requirements

• High School diploma or equivalent required
• 0-1 year of experience in an environmental monitoring or cleanroom setting, ideally within the biotech, pharmaceutical, or cell/gene therapy industries.
• Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
• Ability to follow standard operating procedures (SOPs) and document activities accurately and promptly.
• Comfortable working in a highly controlled cleanroom environment for extended periods.
• Must be available to work 2nd 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 related field preferred

Responsibilities

• Perform routine Environmental Monitoring of Grades A-D Cleanroom environment, including sampling of viable surfaces, viable air and non-viable particulates in a GMP Manufacturing facility.
• 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, 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 trending data and supporting routine EM reporting.
• Adhere to all safety and gowning procedures within classified cleanroom areas.
• Flexibility in following unique campaign requirements that may include off-hour and weekend work.
• Other duties as assigned.

Benefits

• Opportunities for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of within the organization
• Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
• 401K strong employer match
• Tuition Reimbursement
• Employee Referral Bonuses
• Flexible work schedules and Paid Time Off and paid holidays
• Gain experience in the cutting-edge cell therapy space

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED