Sterile Manufacturing Operator

Description:

Empower Pharmacy, a leader in affordable, high-quality compounded medications, is seeking a Sterile Manufacturing Operator (503B) for its Houston, TX facility. This position plays a critical role in producing sterile pharmaceutical products under strict regulatory compliance and aseptic manufacturing standards. The operator will ensure each batch meets Empower’s commitment to safety, precision, and quality in alignment with cGMP (Current Good Manufacturing Practices) guidelines.

This is a full-time, on-site 3rd shift position, ideal for individuals with a meticulous approach to sterile manufacturing, a strong sense of accountability, and the ability to work collaboratively in a cleanroom environment.

Key Responsibilities:

• Execute sterile product manufacturing in compliance with cGMP, 21 CFR Parts 210/211, and USP standards.

• Follow master batch records and standard operating procedures (SOPs) to ensure accuracy and quality in all production activities.

• Utilize aseptic techniques and operate sterile manufacturing equipment with precision.

• Maintain ISO-classified cleanroom environments by performing cleaning, disinfecting, and sterilization tasks for equipment and components.

• Support manufacturing operations, including autoclaving, bubble point testing, inventory management, and Lean manufacturing initiatives (6S, Gemba, Kaizen).

• Participate in sterile operations training programs and assist in coaching new hires.

• Contribute to production schedules and assist with special manufacturing projects as needed.

• Ensure complete and accurate documentation of production processes, adhering to all regulatory requirements.

• Safely handle equipment and materials while maintaining focus on contamination control and product integrity.

Knowledge and Skills:

• Strong attention to detail and commitment to quality standards.

• Excellent problem-solving skills and ability to follow both written and verbal instructions.

• Demonstrated teamwork, adaptability, and collaboration skills in a fast-paced environment.

• Experience in cGMP, Lean manufacturing, or sterile production processes preferred.

• Proficiency in basic math and technical documentation.

• Ability to achieve and maintain “Gown Qualified” status for entry into cleanroom facilities.

• Effective communication skills to work across teams and departments.

Key Competencies:

• Customer Focus: Builds strong relationships and delivers customer-centric solutions.

• Process Optimization: Streamlines work processes with an emphasis on continuous improvement.

• Collaboration: Works effectively with cross-functional teams to achieve shared goals.

• Accountability: Maintains ownership of tasks and ensures production quality standards are met.

• Adaptability: Adjusts effectively to evolving priorities and technical requirements.

• Communication: Clearly conveys information to meet the needs of different audiences.

Core Values:

• People: Foster a culture of growth, support, and community for employees and clients.

• Quality: Uphold excellence in every medication produced.

• Service: Deliver all interactions with empathy and a commitment to service excellence.

• Innovation: Embrace continuous improvement and advanced technologies to enhance pharmaceutical care.

Experience and Qualifications:

• Education: High School Diploma or equivalent (required).

• Experience: Minimum 1 year of prior manufacturing experience preferred.

• Additional Skills: Experience in sterile or cleanroom environments is an advantage.

Work Environment:

• Involves long periods of standing and performing repetitive tasks.

• Requires movement within office and manufacturing areas.

• Physical activities may include reaching, climbing, balancing, stooping, kneeling, crouching, or crawling as needed for operational duties.

Benefits:

Empower Pharmacy provides a comprehensive benefits package designed to support employee health, wellness, and professional growth, including:

• Medical, dental, and vision insurance

• Paid time off (PTO)

• 401(k) with company match

• Wellness perks and employee well-being programs

• IV therapy and access to compounded medications

• Professional development and growth opportunities

More details are available at: https://careers.empowerpharmacy.com/benefits/

About the Organization:

Empower Pharmacy is one of the largest and most innovative compounding pharmacies in the United States, focused on creating affordable, personalized medications that improve patient outcomes. The company’s advanced manufacturing facilities and commitment to cGMP compliance ensure product integrity, safety, and efficacy across all compounded pharmaceuticals.

Empower Pharmacy values its people, quality, and service as the foundation of its culture and continuously innovates to remain at the forefront of pharmaceutical manufacturing.