Environmental Compliance Technician I II

Environmental Compliance Technician I 1st shift 0600am to 230pm with days off of Tueday-Wednesday or Wednesday-Thursday.

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, and passionate Environmental Compliance Technician I to join our St. Louis Missouri team!

ROLE SUMMARY

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.  Lastly, individuals should have a basic understanding of microbiology, have a strong commitment to quality and be comfortable working in a laboratory environment.

ROLE 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. 
• Perform various sampling activities, including viable surface/air samples, non-viable air samples and facility water samples, on a daily basis throughout the aseptic processing area. 
• 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 able to collect/ analyze data. 
• Maintain accurate and concise records with attention to detail.
• Able to deal with frequent change, delays, or unexpected events. 
• When procedural deviations are noted, proper steps are to be taken to notify quality management.  Ethical and integral work is required.
• 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.
• 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.
• 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.

BASIC QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis.

Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls.  Note that these activities may not be time bound to core hours or presence at the site. 

Must have the ability to work effectively under and manage to strict production, time, and performance deadlines.

Must be willing and able to work beyond the hours typically defined as a “regular” workday, including weekends and may or may not include holidays.