Sterile Manufacturing Operator
About the job
- Knowledge of aseptic processing, cleanroom behavior, and contamination-control practices.
- Ability to follow standard operating procedures with precision and maintain strong documentation accuracy.
- Familiarity with current Good Manufacturing Practice requirements, Food and Drug Administration regulations, and sterile manufacturing environments.
- Basic data literacy with the ability to use artificial intelligence-enabled tools to support operational insights and decision-making.
- A high school diploma or equivalent is required.
- Demonstrated ability to follow detailed procedures with a high degree of accuracy.
- Comfort working in cleanroom environments and complying with aseptic gowning requirements.
- Perform sterile compounding and/or filling using validated aseptic techniques in compliance with standard operating procedures and current Good Manufacturing Practice requirements.
- Maintain accurate batch records and electronic documentation, using artificial intelligence-enabled systems to support traceability, documentation quality, and operational efficiency.
- Perform aseptic gowning in accordance with established procedures to support sterile processing activities.
- Conduct cleaning and sanitization of equipment and production rooms, including equipment setup, while maintaining required contamination-control practices.
- Operate, clean, and maintain sterile manufacturing equipment, including isolators and cleanroom systems, ensuring readiness, calibration compliance, and consistent performance aligned with validated production processes and regulatory standards.
- Identify, escalate, and document deviations, non-conformances, and quality events.
- Support root-cause investigations and corrective actions while maintaining adherence to Food and Drug Administration, United States Pharmacopeia, and internal quality requirements.
- Support cleanroom monitoring activities, including sampling and documentation, to maintain compliance with environmental standards.
- Use data insights and artificial intelligence-enabled trend analysis tools to help identify emerging risks and support proactive response.
- Maintain inspection-ready work areas, documentation, and practices.
- Support internal and external audits through disciplined execution and an understanding of regulatory expectations and compliance requirements.
- Execute production schedules efficiently while meeting output targets without compromising quality.
- Use artificial intelligence-driven insights to support improved cycle times, reduced waste, and enhanced manufacturing performance.
- Identify process inefficiencies and recommend improvements, contributing to lean initiatives and leveraging technology to streamline workflows, increase reliability, and support scalable manufacturing operations.
- Partner with Quality, Maintenance, and Production teams to resolve issues, improve processes, and support seamless operations across functions within a regulated manufacturing environment.
- Technical training is preferred.
- Experience in sterile manufacturing, compounding, or another regulated production environment is preferred.
About the company
Empower Pharmacy and Empower Pharma provide personalized, high-quality compounded medications at scale. They customize dosages, remove allergens, and create multi-drug combinations that aren’t available through standard options. Operating with a vertically integrated model as licensed manufacturer, wholesaler, and pharmacy, they streamline the pharmaceutical supply chain to reduce costs without compromising quality. The company serves both healthcare providers (B2B) and individual patients (B2C), manufacturing over 400 medications for millions across all 50 states and internationally. Based in Houston, Texas, Empower runs a 503A compounding pharmacy and a 503B outsourcing facility, focusing on patient safety, excellent service, and advanced technology to expand access to affordable, effective healthcare.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Houston, Texas
Founded
2009
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Simplify's Take
What believers are saying
- Demand for compounded GLP-1 alternatives remains strong despite Novo Nordisk and Eli Lilly shortages ending.
- Empower announced a March 11, 2026 FDA-registered 503B facility, expanding regulated manufacturing capacity.
- LO3 Capital's 2023 investment and Aurobindo asset acquisition support capital access and infrastructure expansion.
What critics are saying
- FDA's September 18, 2026 warning letter cites illegal copycat GLP-1 compounding and sterility failures.
- This is Empower's fifth warning letter since 2017, signaling persistent compliance weaknesses.
- An injunction or seizure after missed remediation would cripple GLP-1 revenue and trigger existential scrutiny.
What makes Empower Pharmacy unique
- Empower runs 503A and 503B facilities, serving clinics with nationwide overnight shipping.
- Empower sells GLP-1 blends like semaglutide-cyanocobalamin and tirzepatide-niacinamide across patient-specific formats.
- Empower has FDA-registered outsourcing capacity and PCAB accreditation, supporting large-scale compounding operations.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Paid Vacation
401(k) Company Match
Wellness Program
Growth & Insights and Company News
6 month growth
28%1 year growth
28%2 year growth
28%FDA warns Pharmacy about illegal GLP-1 compounding. - Agency's letter flagged issues with copycat manufacturing and sterility by Kristen Monaco, Senior Staff Writer, MedPage Today The FDA issued a warning letter this month to Empower Pharmacy over its mass production of compounded GLP-1 weight-loss and diabetes drugs, citing illegal copycat manufacturing and insanitary conditions. Following a facility inspection in November 2025, the agency determined that Empower produced large quantities of drugs that were "essentially copies of FDA-approved semaglutide [Ozempic, Wegovy] and tirzepatide [Mounjaro, Zepbound] products," in violation of Section 503A of the Federal Food, Drug, and Cosmetic Act. "The volume of products you are producing suggests that differences between products you are compounding and the FDA-approved products are pretextual," the FDA wrote in the letter, dated Sept. 18. Under Section 503A, licensed compounding pharmacies are permitted to tailor customized medications for individual patient needs. However, they are prohibited from regularly compounding "in inordinate amounts" any drugs that copy commercially available products without a documented, individualized clinical rationale from a prescriber. Compounded formulations cited in the letter combined active GLP-1 ingredients with added B vitamins - specifically tirzepatide mixed with niacinamide, and semaglutide mixed with cyanocobalamin. Because Empower failed to meet Section 503A conditions, its products lost statutory exemptions and were reclassified as unapproved new drugs and misbranded products. Additionally, FDA inspectors found that sterile drug products were prepared, packed, or held under insanitary conditions and thereby could be "contaminated with filth or rendered injurious to health." Other key violations included: * Failure to perform smoke studies under dynamic conditions to confirm proper airflow in ISO 5 clean room areas * Performing media fills under non-stressful conditions, therefore not guaranteeing aseptic technique * Inadequate environmental monitoring, equipment maintenance, and quality control unit oversight Some of Empower's subsequent corrective actions were adequate while others were deficient, the FDA noted. The compounder has 15 working days to respond. The warning letter follows intensified efforts to crack down on GLP-1 compounding this year. The surge in GLP-1 compounding began a few years ago when high demand triggered widespread shortages. However, shortages of tirzepatide (resolved in December 2024) and semaglutide (resolved in February 2025) have since ended.
Eli Lilly sues Empower Pharmacy over tirzepatide - what medspas need to know ASAP.
HOUSTON, June 21, 2024 /PRNewswire/ -- Empower Pharmacy is pleased to announce its selection as a finalist in the prestigious Best Family-Owned Business Awards, organized by the Houston Business Journal (HBJ). This recognition underscores Empower Pharmacy's commitment to excellence, innovation, and community investment within the Houston business landscape.The Best Family-Owned Business Awards, presented by HBJ, spotlight companies that not only demonstrate financial success but also exhibit a significant commitment to their community investment. Empower Pharmacy was handpicked by HBJ staff and nominated by esteemed members of the Houston business community for its significant impact as an employer and longstanding presence in the region.Empower Pharmacy has been categorized within the large company list, demonstrating its substantial presence and impact as a large employer within the Houston area. To qualify for consideration, all nominees had to meet stringent criteria set by HBJ, including being at least 51% owned by the family, involving multiple generations in company operations, and exhibiting longevity in business."We are honored to be recognized as a finalist in the Best Family-Owned Business Awards," said Shaun Noorian, CEO of Empower Pharmacy. "This acknowledgment reflects our dedication to family values and our deep-rooted commitment to serving our community as we grow. Today, Empower has over 1,000 employees with over 90% located in Houston, and remains a family centered thanks to the hard work and dedication of our entire team."Empower continues to uphold its commitment to providing personalized healthcare solutions of compounded medicines to providers and patients in the Houston area and beyond
Amidst a period of significant expansion, Empower Pharmacy embarks on a strategic rebranding initiative, aimed at enhancing customer and employee experience and reinforcing its commitment to excellenceHOUSTON, May 1, 2024 /PRNewswire/ -- Empower Pharmacy, the country's most advanced compounding pharmacy, today announced a significant milestone with the launch of its brand refresh, signaling the start of a new chapter aimed at enhancing healthcare accessibility and elevating patient, provider, and employee experiences. This comprehensive update reflects the company's commitment to excellence, innovation, and customer-centricity represented by a vibrant brand, redesigned website, and new employee talent program.The brand refresh marks a new era for Empower, highlighting its dedication to enhancing services for customers and employees alike. By actively seeking feedback from both groups, Empower ensures that customers' and employees' needs are met, and experiences continually improved, underscoring the company's ongoing dedication to excellence through responsiveness and improvement."We are launching this fresh approach to meet the needs of our consumers – both patients and providers – on their wellness journey through quality and affordable customized medication," said Shaun Noorian, CEO of Empower. "Our growth throughout the last decade has mirrored the transformation of pharmacy from big box retail brick-and-mortar to consumer-driven health and wellness telehealth." Telehealth is serving consumers nationwide with reportedly more than 35% of individuals aged 18 and over relying on telemedicine in the past year.Empower's Chief Sales and Marketing Officer, Nicole R. Braley, highlighted that "recent surveys indicate that 71% of respondents have turned to online pharmacies in the last one to three years, highlighting the demand for better digital services.1 As part of our strategic rebranding, we are striving to ensure the greater market fully understands the opportunities available through a compounding pharmacy. By exceeding expectations in how we meet their needs, we set a new standard for the industry."Key elements of the brand refresh include a new visual identity that showcases Empower's commitment to excellence and innovation
In February, drug compounder Empower Pharmacy announced that it planned to buy the 170,000-square-foot Eugia facility for an undisclosed price and retain its workforce.