Job Description
Job Description
Job Summary
Cellipont Bioservices operating as Kincellis Advanced Therapies is growing, and we are looking for a 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 CKincellis 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.
The Role
- 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.
The Candidate
- High School diploma or equivalent required; Associate's or Bachelor's degree in Microbiology, Biology, or related field preferred
- 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
Position 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
"At Kincellis Advanced Therapies, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"
Notice to Agency and Search Firm Representatives
Cellipont Bioservices operating as Kincellis Advanced Therapies is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.