Environmental Compliance Technician I - 3rd shift

Kindeva Drug Delivery•St. Louis, MO

1d•Hybrid

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. This position will be based at the St. Louis Brentwood site and offered as a flex role to provide support at the St. Louis Bridgeton site as needed. This position opening is for 3rd shift (10:00pm to 06:30am)

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 and maintain knowledge of company and departmental policies related to current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), safety, health, and security.
Demonstrate practical laboratory knowledge and proficiency in microbiological methodologies, laboratory procedures, and the use of standard laboratory equipment to examine microbiological samples for the presence or absence of microorganisms.
Perform routine environmental monitoring and sampling throughout the aseptic processing facility, including viable surface and air sampling, non-viable air sampling, facility water sampling, compressed gas sampling, and other required sampling activities (CS/AA/PA/Waters/Gas/NVP).
Prepare, label, distribute, and maintain environmental monitoring plates using proper aseptic handling techniques.
Become qualified in aseptic gowning and aseptic technique and maintain compliance with gowning requirements.
Monitor and verify environmental conditions, including temperature, humidity, and differential pressure, using the REES system.
Review, verify, and correct environmental monitoring plate data in MODA to ensure accuracy, completeness, and GMP compliance.
Support quality functions related to batch processing, GMP documentation review, and quality compliance activities.
Support investigations within the QTS system by documenting findings, assisting with root cause investigations, and implementing corrective actions.
Assign Environmental Control (EC) identification numbers to ensure documentation traceability.
Coordinate and complete ad hoc sampling requests in accordance with Environmental Control procedures and applicable protocols.
Assist with smoke studies, Quality Risk Assessments (QRA), protocol-driven sampling, validation activities, and other quality initiatives as needed.
Collect, analyze, interpret, and present laboratory and environmental monitoring data using sound mathematical reasoning and analytical skills.
Maintain accurate, detailed, and concise records with strong attention to detail in accordance with GMP documentation requirements.
Identify procedural deviations and promptly notify Quality Management while maintaining the highest standards of ethics and integrity.
Communicate effectively by listening, seeking clarification from supervisory staff when needed, and presenting written and numerical information clearly and informatively.
Complete assignments on time, develop plans to meet deadlines, and communicate alternative plans when changing priorities or unforeseen circumstances arise.
Adapt effectively to frequent changes, delays, and unexpected events while maintaining productivity and compliance.
Interact professionally and respectfully with management and non-management employees, fostering a collaborative work environment that values diversity and inclusion.
Follow all safety, health, and security procedures and consistently meet departmental safety objectives aligned with job requirements.