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Sterile Manufacturing Supervisor

K2 Staffing
  • Temecula, California
    30+ days ago

    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.

    Numbers & Facts

    LocationTemecula, California

    Skills

    • Asepsisunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Business Supportunmatched
    • Cleanroomunmatched
    • Coachingunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Documentationunmatched
    • Drug Manufacturingunmatched
    • Equipment Maintenance/Repairunmatched
    • FDA (Food and Drug Administration)unmatched
    • GMP (Good Manufacturing Practices)unmatched
    • High School Diplomaunmatched
    • ISO (International Organization for Standardization)unmatched
    • Identify Issuesunmatched
    • Internal Auditunmatched
    • Interpersonal Skillsunmatched
    • Leadershipunmatched
    • Lean Manufacturingunmatched
    • Lean Six Sigmaunmatched
    • Lift/Move 50 Poundsunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Auditunmatched
    • Manufacturing Equipmentunmatched
    • Manufacturing Managementunmatched
    • Manufacturing Operationsunmatched
    • Manufacturing Softwareunmatched
    • Manufacturing Systemsunmatched
    • Material Movingunmatched
    • Medical Equipmentunmatched
    • Microsoft Officeunmatched
    • Multitaskingunmatched
    • NSF Audio Formatsunmatched
    • OSHAunmatched
    • Onboardingunmatched
    • Operational Supportunmatched
    • Operations Planningunmatched
    • Operations Processesunmatched
    • Organizational Skillsunmatched
    • People Managementunmatched
    • Performance Analysisunmatched
    • Performance Metricsunmatched
    • Performance Reviewsunmatched
    • Physical Demandsunmatched
    • Preventative Maintenanceunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Production Controlunmatched
    • Production Managementunmatched
    • Production Scheduleunmatched
    • Production Systemsunmatched
    • Productivity Managementunmatched
    • Quality Assuranceunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Quality Metricsunmatched
    • Quality System Requirements (QSR)unmatched
    • Record Keepingunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Safety Standardsunmatched
    • Staff Developmentunmatched
    • Staff Trainingunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Sterilizationunmatched
    • Team Playerunmatched
    • Warehousingunmatched

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