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Sterile Manufacturing Supervisor

K2 Staffing

Temecula, CALIFORNIA

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JOB DETAILS
SKILLS
Asepsis, Biology, Biotech and Pharmaceutical, Business Support, Cleanroom, Coaching, Communication Skills, Continuous Improvement, Corrective Action, Current Good Manufacturing Practice (cGMP), Documentation, Drug Manufacturing, Equipment Maintenance/Repair, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), High School Diploma, ISO (International Organization for Standardization), Identify Issues, Internal Audit, Interpersonal Skills, Leadership, Lean Manufacturing, Lean Six Sigma, Lift/Move 50 Pounds, Maintain Compliance, Manufacturing, Manufacturing Audit, Manufacturing Equipment, Manufacturing Management, Manufacturing Operations, Manufacturing Software, Manufacturing Systems, Material Moving, Medical Equipment, Microsoft Office, Multitasking, NSF Audio Formats, OSHA, Onboarding, Operational Support, Operations Planning, Operations Processes, Organizational Skills, People Management, Performance Analysis, Performance Metrics, Performance Reviews, Physical Demands, Preventative Maintenance, Problem Solving Skills, Process Improvement, Production Control, Production Management, Production Schedule, Production Systems, Productivity Management, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Quality System Requirements (QSR), Record Keeping, Regulations, Regulatory Compliance, Safety Standards, Staff Development, Staff Training, Standard Operating Procedures (SOP), Sterilization, Team Player, Warehousing
LOCATION
Temecula, CALIFORNIA
POSTED
7 days ago
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  

About the Company

K

K2 Staffing