QC Environmental Monitoring Technician - Night Shift

Position Description

Provide support for Parenteral Operations by performing environmental monitoring of the classified manufacturing areas and by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings. The QC Expert Environmental Monitoring Technician will assist the QC Environmental Monitoring management with training other QC Environmental Monitoring Technicians and providing support in the manufacturing areas during routine environmental monitoring and utility sampling.

Key Objectives/Deliverables

• Adhere to and promote compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.
• Provide support for Parenteral Operations activities by performing environmental monitoring of classified manufacturing areas.
• Provide support for manufacturing and laboratory activities by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings.
• Assist with technical training and mentoring of QC Environmental Monitoring Technicians through formal process/program.
• Participate in department/company continuous improvement projects and initiatives.
• Assist with authoring Standard Operating Procedures and Work Instruction documentation.
• Adhere to and promote compliance of all safety standards.

Minimum Requirements

Education: High School Diploma or equivalent, Associate Degree is preferred.

Experience: 2+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production. Demonstrated ability in performing environmental monitoring techniques including, but not limited to viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and water (potable, purified water, water for injection, clean steam) collection and analysis. Previous experience with Laboratory IT systems such as LIMs, LES, and MODA. Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

• Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
• Strong interpersonal skills and ability to train/mentor QC Environmental Monitoring Technicians.
• Strong oral and written communication skills for communicating to colleagues, management, and other departments.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
• Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.

Other Information

The role will be phased from a project support role to a routine support role as the development facility and processes progress. During the project phase the working schedule will vary (typically M-F 8 hours). In operation, must have ability to work 12-hour night shift (2-2-3 structure). Travel will be required during the project phase for training and implementation of the Environmental Monitoring Program for the Concord site. Tasks may require repetitive motion and standing or walking for long periods of time. Tasks may require lifting of up to 30 pounds and may require the ability to pass, push, and pull to execute specific aspects of the job role.