Role Overview
The Filling Line Lead operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and serves as the primary day‑to‑day operations lead for the filling line, ensuring safe, efficient, and compliant production throughout the shift.
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 standards.
- 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 initiative 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.
- Maintain a high level of safety, quality, and productivity to ensure reliable supply of products to patients.
- Promptly report and assist in the investigation of any contamination events or deviations.
- Support departmental objectives including improving safety and performance, reducing deviations, and ensuring training compliance.
- Perform other duties as assigned by management.
Qualifications
Education & Experience
- High School Diploma, GED, or equivalent required; Associates degree preferred.
- Minimum of 5 years of work‑specific experience as Production Operator or Production Setup Operator in a pharmaceutical manufacturing environment.
- Basic computer literacy, including word processing, spreadsheets, and email communication.
- Strong knowledge of aseptic processing, cleanroom standards, and sterile techniques.
- 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.
Physical Requirements
- Ability to stand and sit for extended periods.
- Must be able to lift a minimum of 50 lbs.
- Ability to operate an electric pallet jack.
- When required, physically able to wear full cleanroom gowning, including gloves, mask, and other protective gear.
Cognitive Requirements
- Ability to read and understand military time.
- High degree of manual dexterity to perform tasks using aseptic techniques under restrictive 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.
Benefits
- Global leader in diagnostic and interventional imaging offering professional growth opportunities.
- Collaborative and inclusive work environment with a diverse team of over 2,800 professionals.
- Commitment to diversity, equity, and inclusion.
Equal Opportunity Employer
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.
Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or call +1 984-344-3717.