QC - Environmental Monitoring Technician (Day Shift)

100 Eli Lilly and Company; Concord (NC); On-site; USD 26,000 - 50,000; Full time

Job summary

Lilly in Concord, NC is building a state-of-the-art Parenteral Operations QC Lab. The QC Environmental Monitoring Technician will perform environmental monitoring of classified manufacturing areas and assist with training QC Environmental Monitoring Technicians during development and operations.

The role emphasizes cGMP compliance, SOP documentation, and collaboration across manufacturing and quality systems. 12-hour shifts and travel during project phases are expected.

Qualifications

• High School Diploma or equivalent; Associate degree preferred.
• 3+ years in environmental monitoring in GMP pharmaceutical manufacturing.
• Experience with viable surface monitoring and air and water sampling.
• Familiarity with LIMs, LES, and MODA.

Responsibilities

• Perform environmental monitoring in classified manufacturing areas.
• Support Parenteral Operations with utility sampling and analysis.
• Train and mentor QC Environmental Monitoring Technicians.
• Assist with SOPs and Work Instructions; ensure safety and compliance.

Skills

Environmental Monitoring

LIMS

LES

MODA

Education

High School Diploma

Associate Degree preferred

Tools

LIMS

LES

MODA

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Quality Control Laboratory ensures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

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.

Position Description

The QC Environmental Monitoring Technician will 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 Environmental Monitoring Technician will assist the QC Environmental Monitoring management with training 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: 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

• 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.
• 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.
• Ability to work 12-hour shifts.
• Ability to have a flexible schedule as the position may require training or working on day/night shift for a short duration prior to transitioning to designated day/night shift.
• Travel will be required during the project phase for training and implementation of the Environmental Monitoring Program for the Concord site.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance.

Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $18.75 - $35.96. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k), pension, vacation benefits, eligibility for medical, dental, vision and prescription drug benefits, flexible benefits (e.g., healthcare and/or dependent day-care flexible spending accounts), life insurance and death benefits, certain time off and leave of absence benefits, and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly