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Sterile Manufacturing Supervisor

K2 Staffing
  • Temecula, CALIFORNIA
  • Quick Apply
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.
Employment Type: Full time Location: Temecula, CA  

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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