Lead Environmental Monitoring Technician - Night Shift

Initial Therapeutics, Inc.; Concord (NC); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a QC Environmental Monitoring Lead to oversee and guide a team of Environmental Monitoring Technicians. This role is crucial in ensuring compliance with cGMP procedures and quality systems while performing environmental monitoring in a state-of-the-art facility. The position offers an exciting opportunity to contribute to the development of a new facility and improve the safety and efficacy of drug products. If you are passionate about quality control and eager to make a difference in the healthcare sector, this role is perfect for you.

Qualifications

• 2-3+ years of experience in Environmental Monitoring in a GMP facility.
• Ability to perform environmental monitoring techniques and analysis.

Responsibilities

• Oversee QC Environmental Monitoring Technicians and their activities.
• Perform environmental monitoring and utility sampling in manufacturing areas.
• Assist in training and mentoring QC Environmental Monitoring Technicians.

Skills

Environmental Monitoring

cGMP Compliance

Analytical Skills

Interpersonal Skills

Communication Skills

Education

High School Diploma

Associate's Degree

Bachelor's Degree in Science

Tools

Laboratory IT Systems (LIMs, LES, MODA)

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Company Overview:

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

Position Description:

The QC Environmental Monitoring Lead will assist management in providing oversight and guidance for the QC Environmental Monitoring Technicians. The QC Environmental Monitoring Lead will assist management in coordination of environmental monitoring activities to be performed in support of Parenteral Operations and routine facility monitoring requirements. Additionally, the QC Environmental Monitoring Lead will assist in training the QC Environmental Monitoring Technicians and perform routine environmental monitoring and utility sampling in the manufacturing areas.

Key Objectives/Deliverables:

1. Ensure and enforce compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.
2. Provide support for Parenteral Operations activities by performing environmental monitoring of classified manufacturing areas.
3. Provide support for manufacturing and laboratory activities by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings.
4. 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.
5. Assist management in coordinating environmental monitoring activities for the QC Environmental Monitoring Technician(s).
6. Perform technical training and mentor QC Environmental Monitoring Technicians through formal process/program.
7. Provide shift support for QC Environmental Monitoring Technicians when non-routine events occur and escalate to management as required.
8. Assist with authoring Standard Operating Procedures and Work Instruction documentation.
9. Adhere to and promote compliance of all safety standards.
10. Perform environmental monitoring of classified manufacturing areas for Parenteral Operations activities.
11. Perform utility sampling and analysis for manufacturing and QC laboratory.

Minimum 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.

Additional Preferences:

• 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.

Other 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 Training phase the working schedule will vary (typically M-F 8 hours). In operation, must have ability to work a 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.

The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.