Sterile Manufacturing Supervisor

Job Description

Job Description

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.