Technician – QC Lab - Lebanon

Role Summary

Technician – QC Lab - Lebanon. The technician participates in environmental and utilities monitoring for site buildings, with potential involvement in aseptic testing, incubation, and analysis of environmental monitoring samples. Based in Lebanon, IN upon construction of the API manufacturing facility, otherwise primarily supporting the project team in Indianapolis.

Responsibilities

• Perform environmental monitoring sampling (non-viable, viable, surface, and personnel) in site manufacturing and support facilities.
• Perform utility sampling (non-viable, viable, oil content, dew point, and purity) on compressed gas systems.
• Perform sampling on water systems.
• Participate in performance qualification of environmental, utility, and water systems.
• Data entry and review for accuracy in accordance with laboratory procedures, standards, and GMP requirements.
• Train others within the lab, as required.
• Perform routine equipment qualifications/calibrations or maintenance via well-defined protocols.
• Troubleshoot equipment and methods as required.
• Ensure complete and effective monitoring data using electronic systems and maintain data integrity.
• Second Person Verify (SPV) data of other technicians as required.
• Ensure compliance with cGMPs and assist in investigations of non-conformance issues; recognize deviations and initiate investigations.
• Communicate with management as required by procedures or standards.
• Maintain a safe work environment and support HSE goals; support inspection-readiness.

Qualifications

• Required: Associate degree (2 year) in a science field such as microbiology or biology, or High School Diploma with 2 years of relevant GMP experience.
• Preferred: Ability to work in a highly regulated lab environment with appropriate PPE; understanding of cGMPs, environmental monitoring procedures, processes, and equipment.

Skills

• Strong written and oral communication, troubleshooting and investigative abilities, and critical thinking.
• Attention to detail and ability to meet deadlines by organizing and prioritizing tasks.
• Proficiency with computer systems, instrument-specific applications, and Microsoft Office.

Education

• As listed in Qualifications above.

Additional Requirements

• Role may require 24-hour operations with shifts covering days, nights, and weekends; overtime and off-shift availability for operational issues.
• Physical requirements: may involve repetitive motion and standing for long periods; must be able to lift at least 30 pounds.