Summary
We are seeking an experienced Sterile Filling Line Supervisor to lead clean room manufacturing operations within a fast-growing nutritional and pharmaceutical-grade production environment. This individual will play a critical role in overseeing sterile filling operations, ensuring equipment runs efficiently, production goals are achieved, and all activities comply with GMP, quality, and safety standards.
The ideal candidate will possess a strong background in sterile manufacturing, pharmaceutical, nutraceutical, biotechnology, medical device, or other regulated production environments. This is a hands-on leadership role responsible for setting up, operating, troubleshooting, and optimizing sterile filling equipment while supervising production personnel and maintaining the highest standards of product quality and regulatory compliance.
Duties & Responsibilities
- Production & Equipment Operations
- Set up, operate, monitor, and troubleshoot sterile filling and bottling equipment to ensure efficient and compliant production operations.
- Perform equipment changeovers, adjustments, calibrations, and line clearances as required.
- Ensure filling lines consistently meet production, quality, and efficiency targets.
- Identify and resolve equipment, process, and operational issues to minimize downtime and maximize throughput.
- Coordinate preventative maintenance activities and work closely with maintenance personnel to ensure equipment reliability.
- Monitor production schedules and adjust staffing and resources as necessary to meet operational demands.
- Leadership & Personnel Management
- Supervise, train, coach, and develop production personnel assigned to sterile filling and bottling operations.
- Ensure team members follow all Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), and clean room protocols.
- Conduct performance evaluations, provide ongoing feedback, and support employee development initiatives.
- Foster a culture of accountability, teamwork, safety, and continuous improvement.
- Assist with staffing decisions, onboarding, and training of new employees.
- Quality & Compliance
- Ensure all manufacturing activities comply with cGMP, FDA, OSHA, and company quality standards.
- Review and maintain accurate batch records, production logs, and manufacturing documentation.
- Verify completion of in-process inspections and quality checks throughout production activities.
- Support internal audits, regulatory inspections, investigations, corrective actions, and continuous improvement initiatives.
- Ensure strict adherence to aseptic processing, contamination control, and clean room procedures.
- Operational Excellence
- Monitor key performance indicators including throughput, yields, downtime, waste reduction, and labor efficiency.
- Recommend and implement process improvements that increase productivity while maintaining product quality.
- Collaborate with Quality Assurance, Quality Control, Warehouse, Planning, and Operations teams to support overall business objectives.
- Maintain a clean, organized, and audit-ready manufacturing environment.
Qualifications & Requirements
- Education
- High School Diploma or GED required.
- Associate's or Bachelor's degree in Engineering, Manufacturing, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field preferred.
- Experience
- Minimum of 5 years of manufacturing experience within a pharmaceutical, nutraceutical, biotechnology, medical device, cosmetic, or other regulated production environment.
- Minimum of 2 years of supervisory or leadership experience overseeing production personnel.
- Proven experience operating, setting up, troubleshooting, and optimizing filling, bottling, packaging, or related manufacturing equipment.
- Experience working within clean room and sterile manufacturing environments strongly preferred.
- Experience with aseptic processing and contamination control practices is highly desirable.
- Technical Skills
- Strong knowledge of GMP, cGMP, FDA, and quality system requirements.
- Familiarity with batch records, manufacturing documentation, deviation reporting, and corrective actions.
- Ability to diagnose and resolve mechanical, operational, and production issues.
- Proficiency with manufacturing software systems and Microsoft Office applications.
- Strong understanding of lean manufacturing principles and continuous improvement methodologies.
- Leadership Competencies
- Demonstrated ability to lead, motivate, and develop production teams.
- Strong decision-making, problem-solving, and organizational skills.
- Excellent communication and interpersonal abilities.
- Ability to effectively manage multiple priorities in a fast-paced manufacturing environment.
- Physical Requirements
- Ability to stand, walk, bend, and perform production-related activities throughout the workday.
- Ability to lift and move materials weighing up to 50 pounds.
- Ability to wear required clean room attire, including gowns, gloves, masks, hairnets, and other personal protective equipment for extended periods.
- Preferred Qualifications
- Experience supervising sterile filling, bottling, packaging, or aseptic manufacturing operations.
- Lean Manufacturing, Six Sigma, or Continuous Improvement training.
- GMP, cGMP, or pharmaceutical manufacturing certifications.
- Experience preparing for and participating in FDA, ISO, NSF, or customer audits.