Lead Environmental Monitoring Technician

1 month ago

Concord, North Carolina, United States BioSpace, Inc. Full time
Job Overview:

We are seeking a highly skilled Environmental Monitoring Lead to join our team at Lilly. As a key member of our Quality Control Laboratory, you will be responsible for providing oversight and guidance for our QC Environmental Monitoring Technicians. Your expertise will be crucial in ensuring compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.

Key Responsibilities:

• Ensure and enforce 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 management in providing oversight of the QC Environmental Monitoring Technicians during the day-to-day activities, including any non-routine day-to-day activities (i.e., Media Fills, EM PQs) that may arise based on production needs.
• Assist management in coordinating environmental monitoring activities for the QC Environmental Monitoring Technician(s).
• Perform technical training and mentor QC Environmental Monitoring Technicians through formal process/program.
• Provide shift support for QC Environmental Monitoring Technicians when non-routine events occur and escalate to management as required.
• Assist with authoring Standard Operating Procedures and Work Instruction documentation.
• Adhere to and promote compliance of all safety standards.
• Perform environmental monitoring of classified manufacturing areas for Parenteral Operations activities.
• Perform utility sampling and analysis for manufacturing and QC laboratory.

Requirements:

• Education: High School Diploma or equivalent, Associate's degree or equivalent, Bachelor's (4-year) degree in a science related field is preferred.
• Experience: 2 - 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.

Preferred Qualifications:

• High level of experience with cGMP requirements, compliance, and regulatory guidance associated with a cGMP Pharmaceutical Manufacturing facility.
• Possess interpersonal skills and teaching/coaching experience.
• Possess oral and written communication skills for communicating to employees, 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.

Additional Information:

The role will be phased from a project support role to a routine support role as the development facility and processes progress. 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. 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 structure. Travel will be required during the project phase for training and implementation of the Environmental Monitoring Program for the Concord site.

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