Environmental Compliance Technician I- 2nd Shift

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with customers to improve patient outcomes worldwide.

About the role

We are hiring an Environmental Compliance Technician I to join our St. Louis, Missouri team. This role involves performing environmental monitoring of the Aseptic Processing Area (APA) and related activities both inside and outside the cleanroom. The position is based at the St. Louis Brentwood site with flexibility to support the St. Louis Bridgeton site as needed.

This is a 2nd shift role (14:00–22:30). Training will begin on first shift hours (06:00–14:30), Monday through Friday, and may vary between sites. Scheduling, including assigned days off, may be adjusted to support evolving business needs.

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.

Requirements

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

Qualifications

• Associate degree or bachelor’s degree in biology, microbiology, or a related field is preferred.
• Previous experience in a relevant field is preferred.

Schedule

2nd shift (14:00–22:30). Training will begin on first shift (06:00–14:30), Monday through Friday, and may vary between sites.