Environmental Compliance Technician

Kindeva Drug Delivery•St. Louis, MO

About The Position

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows. Ready to work with purpose? Look no further, we are hiring for a motivated – talented – passionate, etc.} Environmental Compliance Technician I to join our St. Louis Missouri team! The main responsibilities of an Environmental Compliance Technician I involve performing environmental monitoring of the Aseptic Processing Area (APA). Individuals will also perform activities outside of the cleanroom including the examination of environmental monitoring samples for the recovery of microbial growth and the entry of data into a validated database. Sampling activities for this position includes viable surface and air monitoring, non-viable air monitoring and water sampling across the facility. Individuals for this role should have strong leadership and interpersonal skills. Additionally, individuals should be respectful of others and be well respected by their peers. The individual should be comfortable working independently and be able to manage multiple activities occurring simultaneously. Individuals should have a basic understanding of microbiology, have a strong commitment to quality and be comfortable working in a laboratory environment. Lastly, it is important to note that EC Technicians should expect some flexibility in their work schedules. Scheduling needs may change throughout their time with Kindeva to ensure adequate support for production operations at both the Brentwood and Bridgeton facilities. These adjustments are driven by business needs and production demands.

Requirements

High School/GED and one-year general work experience, and/or training; or equivalent combination of education and experience.

Nice To Haves

Associate degree or bachelor’s degree in biology, microbiology, or related field and previous experience preferred.

Responsibilities

Acquire proper knowledge and understanding of company and departmental policies pertaining to current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), safety, health, and security.
Required to actively demonstrate knowledge of practical laboratory skills, methodologies, and procedures. Employees must be capable of using standard laboratory equipment and able to examine microbiological survey samples for the absence or presence of microbiological organisms.
Must have mathematical reasoning skills and be able to collect/ analyze data.
Able to listen and obtain clarification from supervisory staff as required. Must be capable of writing clearly and informatively. Capable of evaluating and presenting numerical data effectively.
Capable of completing tasks on time. Must be able to develop a plan or notify appropriate staff of when alternative plans are required.
When procedural deviations are noted, proper steps are to be taken to notify quality management. Ethical and integral work is required.
Must be able to interact with management and non-management employees. Treat others with respect and consideration regardless of their status, position and personal or cultural differences.
Maintain accurate and concise records with attention to detail.
Able to deal with frequent changes, delays, or unexpected events.
Follow all safety and security procedures. Meet department safety objectives consistent with the job requirements.
Become qualified on aseptic gowning and technique.
Support quality functions involved in batch processing and GMP paperwork review.
Review and correct plate data in MODA to ensure accuracy and completeness.
Monitor and verify temperature, humidity, and pressure conditions using the REES system.
Perform routine sampling (CS/AA/PA/Waters/Gas,NVP) throughout entire facility.
Prepare, label, and distribute monitoring plates while maintaining aseptic handling procedures.
Support investigation activities within the QTS system, documenting findings and corrective actions.
Assign EC identification numbers to ensure traceability of all documentation.
Coordinate and complete adhoc sampling requests in accordance with EC procedures when applicable.
Assist with smoke studies, QRA, and protocol-based sampling as needed.