Pharmaceutical Production Lead - 2nd Shift

Medline•Waukegan, IL

1d•Onsite

About The Position

This role is responsible for performing advanced pharmaceutical drug manufacturing activities and providing day-to-day technical guidance and workflow coordination within regulated GMP environments. The Production Lead serves as a technical and operational resource on the production floor, supporting production flow, compliance, and continuous improvement without formal supervisory authority. The position operates on a 2nd Shift, Monday through Friday, from 2:00 PM to 10:30 PM.

Requirements

High school diploma or GED required
2-3 years of manufacturing experience.
Experience in aseptic manufacturing experience in GMP and ISO-cleanroom environments.
Proven ability to operate, monitor, troubleshoot, and maintain biopharmaceutical manufacturing equipment.
Demonstrated attention to detail with the ability to accurately complete GMP documentation and support investigations and escalate issues.
Effective communication and interpersonal skills, including the ability to guide and collaborate with others.
Comfortable working in cleanroom and controlled environments while adhering to gowning, safety, and quality requirements.
Flexibility to work mandatory overtime based on business needs.
Ability to speak, read, and write English with proficiency

Nice To Haves

Bachelor's degree in STEM field
2 years of hands-on experience in GMP-regulated pharmaceutical or biopharmaceutical manufacturing.
Demonstrated experience performing advanced manufacturing operations such as aseptic processing, media/buffer preparation, and equipment operation
Advanced knowledge of upstream and/or downstream bioprocessing operations
Experience supporting audits, inspections, and regulatory interactions
Familiarity with continuous improvement methodologies and operational excellence initiatives
Strong problem-solving skills with the ability to work cross-functionally

Responsibilities

Acts as a technical and workflow lead by coordinating daily manufacturing tasks, prioritizing activities, and supporting efficient production flow without formal people management responsibility.
Provides on-the-job guidance, mentoring, and training to manufacturing technicians and lower-level operators to ensure adherence to procedures, safety standards, and GMP requirements.
Performs advanced, hands-on biopharmaceutical manufacturing activities, including media and buffer preparation, aseptic processing, equipment cleaning and sterilization, and any responsibilities to support production and schedule adherence.
Sets up, operates, monitors, and adjusts bioprocessing equipment such as autoclaves, washer-sterilizers, filtration systems, fermenters, and fill-finish equipment.
Prepares, cleans, assembles, and stages tanks, glassware, components, and systems for batch manufacturing operations in accordance with approved procedures.
Monitors critical process parameters, production data, and outputs to ensure compliance with batch records, specifications, and quality standards.
Identifies, documents, and escalates deviations, abnormal events, and process issues in accordance with quality systems and regulatory expectations.
Maintains accurate and complete batch documentation, equipment logs, inventory records, and other GMP compliance documentation.
Follows and reinforces standard operating procedures (SOPs), manufacturing instructions, and all applicable safety, quality, and regulatory guidelines.
Collaborates with engineering, quality, and maintenance teams on troubleshooting, investigations, testing, and process optimization activities.
Supports continuous improvement initiatives by providing technical input, identifying opportunities for efficiency or quality improvements, and assisting with implementation of approved changes.