Sterile Manufacturing Supervisor
3 days ago
Temecula
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.Company DescriptionK2 Staffing has been constructed on one of the most solid foundations in the industry, with roughly 40 years of combined business and recruiting knowledge. Through our vast experience, we understand locating and attracting the right talent can be comparable to ascending K2 - difficult, sometimes impossible, and potentially savage. With that said, we take a very methodical approach with our process, including a detailed discovery process ultimately leading to a customized plan of action for each of our clients. Our “high-tech, soft-touch” technique produces results that cannot be denied. We have embraced technology to its fullest, which provides us with top-quality candidates to choose from. That, however, does not disclude how important it is to roll up our sleeves and connect with people on a human level, avoiding short-term arrangements, disappointment, and a tremendous waste of time and money for all parties involved. Whether you are a candidate seeking to locate a company to represent for the long haul, or you are a hiring manager for an organization searching for that 1 in a million, K2 Staffing is here to assist you. Utilizing our “high-tech, soft-touch” approach, we will successfully diagnose the needs and desires of both our clients and candidates, resulting in the perfect connection for years to come. Mission: “To alter the landscape of the staffing world incorporating a high-tech, soft-touch approach, connecting corporations with people, resulting in opportunities that enhance and improve the lives of others.” Vision: “Through positivity, desire, belief, and inspiration, we will be recognized as the new standard in the recruitment industry.”K2 Staffing has been constructed on one of the most solid foundations in the industry, with roughly 40 years of combined business and recruiting knowledge. Through our vast experience, we understand locating and attracting the right talent can be comparable to ascending K2 - difficult, sometimes impossible, and potentially savage. With that said, we take a very methodical approach with our process, including a detailed discovery process ultimately leading to a customized plan of action for each of our clients. Our “high-tech, soft-touch” technique produces results that cannot be denied. We have embraced technology to its fullest, which provides us with top-quality candidates to choose from. That, however, does not disclude how important it is to roll up our sleeves and connect with people on a human level, avoiding short-term arrangements, disappointment, and a tremendous waste of time and money for all parties involved. \r\n\r\nWhether you are a candidate seeking to locate a company to represent for the long haul, or you are a hiring manager for an organization searching for that 1 in a million, K2 Staffing is here to assist you. Utilizing our “high-tech, soft-touch” approach, we will successfully diagnose the needs and desires of both our clients and candidates, resulting in the perfect connection for years to come. \r\n\r\nMission:\r\n\r\n“To alter the landscape of the staffing world incorporating a high-tech, soft-touch approach, connecting corporations with people, resulting in opportunities that enhance and improve the lives of others.” \r\n\r\nVision:\r\n\r\n“Through positivity, desire, belief, and inspiration, we will be recognized as the new standard in the recruitment industry.”