Sterile Manufacturing Supervisor
Location: Temecula, CA
Job Type: Full time
Company: K2 Staffing
Category: Manufacturing
Job Description Apply Now
The Sterile Manufacturing Supervisor plays a pivotal leadership role within sterile production environments, overseeing all aspects of clean room operations related to sterile filling and bottling. This position is essential for maintaining compliance with strict regulatory standards, ensuring product quality, and optimizing manufacturing efficiency. As a key supervisor, you will be responsible for managing both the technical and personnel aspects of sterile manufacturing, driving operational excellence, and cultivating a culture of continuous improvement throughout the production process.
In this full-time Sterile Manufacturing Supervisor role, you will work within a dynamic and fast-paced pharmaceutical or nutraceutical production setting. You will leverage your deep experience in regulated manufacturing environments to lead a team of dedicated production personnel, ensuring that sterile filling operations consistently meet or exceed production targets while adhering to Good Manufacturing Practices (GMP), FDA, OSHA, and company-specific quality requirements. Your expertise in sterile manufacturing, equipment operations, and team management will be critical to achieving optimal results and supporting the company's mission of delivering high-quality, safe products to consumers.
Working as a Sterile Manufacturing Supervisor in Temecula, CA, offers the unique opportunity to contribute to a thriving hub of pharmaceutical and biotechnology innovation. The region is recognized for its commitment to quality and regulatory excellence, providing a collaborative atmosphere for professionals who are passionate about advancing the standards of sterile production.
This supervisory position is ideal for individuals with a proven background in sterile manufacturing, biotechnology, medical device production, or regulated environments. You will be responsible for setting up, operating, troubleshooting, and optimizing sterile filling equipment, as well as supervising production personnel to ensure the highest standards of product quality and regulatory compliance are consistently achieved. Your role will also involve active participation in process optimization, regulatory audits, and continuous improvement initiatives that drive operational efficiency and maintain a safe, compliant workplace.
As a Sterile Manufacturing Supervisor, you will be a hands-on leader, directly involved in the daily operations of the sterile filling line. You will ensure that all equipment is maintained in excellent working order, production schedules are met, and all manufacturing activities adhere to rigorous aseptic processing protocols. Your ability to mentor, coach, and develop your team will be essential in fostering a high-performance culture that values safety, accountability, and teamwork.
If you are seeking a challenging and rewarding role as a Sterile Manufacturing Supervisor and are ready to make a significant impact in a regulated production environment, we encourage you to apply by clicking the job application button. Join a company that values your expertise and offers opportunities for professional growth and advancement within the sterile manufacturing industry.
Sterile Manufacturing Supervisor - Summary- Lead, supervise, and optimize sterile filling and clean room manufacturing operations in compliance with GMP, FDA, and company standards.
- Oversee production personnel, ensuring proper training, adherence to SOPs, and continuous development.
- Drive operational efficiency, equipment reliability, and product quality within a regulated manufacturing environment.
- Set up, operate, monitor, and troubleshoot sterile filling and bottling equipment to ensure efficient production.
- Perform equipment changeovers, adjustments, and preventative maintenance in collaboration with maintenance teams.
- Supervise, train, and evaluate production staff in accordance with SOPs and clean room protocols.
- Monitor production schedules, adjust resources as needed, and ensure production targets are consistently met.
- Ensure strict compliance with cGMP, FDA, OSHA, and company quality standards across all manufacturing activities.
- Review batch records, maintain accurate production documentation, and support regulatory audits and inspections.
- Identify and implement process improvements for increased productivity and reduced waste.
- Foster a culture of safety, teamwork, accountability, and continuous improvement within the production team.
- Competitive compensation package commensurate with industry standards.
- Comprehensive benefits typically include health, dental, and vision insurance, retirement plans, paid time off, and professional development opportunities.
- Career growth potential within a leading sterile manufacturing organization.
- High School Diploma or GED required; Associate's or Bachelor's degree in Engineering, Manufacturing, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field preferred.
- Minimum 5 years of experience in regulated manufacturing environments such as pharmaceutical, biotechnology, or nutraceutical production.
- At least 2 years of supervisory or leadership experience in a manufacturing setting.
- Experience with sterile filling, bottling, packaging, or aseptic manufacturing operations.
- Strong knowledge of GMP, cGMP, FDA, and quality system requirements.
- Ability to diagnose and resolve technical, operational, and production issues.
- Proficiency with manufacturing software systems and Microsoft Office applications.
- Physical ability to perform production activities, including lifting up to 50 pounds and wearing clean room attire for extended periods.
- Demonstrated leadership skills, including the ability to motivate, coach, and develop production teams.
- Excellent organizational, decision-making, and problem-solving abilities.
- Strong communication and interpersonal skills, with the ability to manage multiple priorities in a fast-paced environment.
- Experience with lean manufacturing, Six Sigma, or continuous improvement methodologies is a plus.
- Certifications in GMP, cGMP, or pharmaceutical manufacturing are highly desirable.
- Track record of supporting successful regulatory audits and compliance initiatives.
- This is a full-time position based in a leading sterile manufacturing facility.
- Excellent opportunity to expand your skills in a thriving industry with strong compliance and operational standards.
- Applicants who thrive in regulated, team-oriented environments and are dedicated to quality improvement are highly encouraged to apply.
- To be considered for the Sterile Manufacturing Supervisor position, please click the job application button to submit your application.
- The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.