Filling Line Lead

Laboratoire Guerbet•Raleigh, IL

3d•Onsite

About The Position

The Filling Line Lead operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The Filling Line Lead will be an active, hands-on participant in all line operations and will serve as the primary day-to-day operations lead, supporting the team to ensure safe, efficient, and compliant production throughout the shift. The Filling Line Lead acts as the primary point of contact for troubleshooting, training, and workflow coordination during shift operations. The Filling Line Lead will also be responsible for completing all necessary documentation related to the manufacturing process while adhering to cGMP and GDP guidelines.

Requirements

High School Diploma, GED, or equivalent required.
Minimum of 5 years of work-specific experience as Production Operator or Production Setup Operator in a pharmaceutical manufacturing environment required.
Basic computer literacy, including the ability to use word processing software, spreadsheet programs, and electronic mail communication tools required.
Strong knowledge of aseptic processing, cleanroom standards, and sterile techniques required.
Ability to stand and sit for extended amounts of time.
Must be able to lift a minimum of 50 lbs.
Ability to operate an electric pallet jack.
When required, must be physically able to wear full clean room gowning, including gloves, mask, and other protective gear.
Ability to read and understand military time is required.
Requires a high degree of manual dexterity to perform tasks using aseptic techniques under restrictive or controlled conditions.
Strong verbal and interpersonal communication skills.
Excellent reading comprehension and attention to detail for interpreting batch records and SOPs.
Strong mathematical aptitude for accurate measurements and calculations.
Mental and visual acuity for production of quality products.
Highly skilled in problem-solving and diagnostic abilities.
Demonstrates initiative and sound decision making while working effectively both independently and as part of a team.
Demonstrates strong attention to detail in all tasks to ensure accuracy and compliance.
Ability to prioritize tasks and lead a team in a fast-paced, regulated environment.

Nice To Haves

Associates degree preferred.
Experience providing leadership, guidance, or oversight to team members in a fast-paced operational setting preferred.
Experience navigating SAP or similar ERP systems to support daily operational tasks preferred.

Responsibilities

Oversee day-to-day operation of the filling line, ensuring production targets for volume, quality, and efficiency are met.
Assign daily tasks to line operators based on staffing and production requirements.
Verify correct materials, components, and documentation before initiating production.
Provide on-the-job coaching and training for new and existing employees.
Monitor employee performance and adherence to SOPs, safety guidelines, and quality standard.
Foster a positive, collaborative team environment that drives strong engagement and high productivity.
Support the training and ongoing development of new hires, temporary workers, and current employees.
Exhibit initiatives by independently addressing tasks, challenges, and operational needs.
Provide performance feedback to assist the Filling Supervisor with employee reviews.
Provide timely, accurate communication regarding production delays to supervisors, managers, and other key stakeholders.
Ensure all production documentation meets GMP and GDP standards, identifying errors or discrepancies and coordinating timely corrections.
Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.) in an aseptic environment.
Ensure high level of safety, quality, and productivity to maintain reliable supply of products to patients.
Promptly report and assist in investigation of any contamination events or deviations.
Supports departmental objectives including improving safety and performance, reducing deviations, and training compliance.
Performs other duties as assigned by management.