QC Environmental Monitoring Technician - Night Shift - Relocation to Concord, NC
Lilly
- Huntington, WV
- Permanent
- Full-time
- 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.
- Education
- High School Diploma or equivalent, Associate Degree is preferred.
- Experience
- 3+ 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.
- 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.
- 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.