Sterile Compounding Process and Validation En

Job Description

Job Description

MISSION STATEMENT

Boudreaux's New Drug Store has a mission to provide accessible, compassionate, and exceptional pharmaceutical care to every patient we serve. We are dedicated to promoting health and wellness within our community by offering personalized medication to best suit the needs of the individual. Our expert guidance and commitment to customer service allows us to be the trusted partner in optimizing the quality of life for our customers. Our goal is to consistently exceed expectations, foster enduring relationships, and create a positive experience for everyone within our community and beyond. 

At Boudreaux's New Drug Store, our vision is to become the staple in pharmaceutical care and to be recognized for our unwavering dedication to enhancing the health and wellness of every individual we serve. We aspire to be the model for excellence in the healthcare industry, crafting innovative solutions and setting new standards of excellence in patient care. Our vision encompasses a future where Boudreaux's leads the field in medical expertise and care. We want each customer to take control of their health journey and allow our pharmacy to support their commitment with compassionate expertise and care. Through continuous growth, collaboration, and expert advice, we envision a healthier future for each individual we serve. 

Boudreaux's New Drug Store will serve the patient-physician need by preparing CUSTOM FORMULATIONS. Upon physician request, medications will be prepared according to the patient's demographic and specific etiological requirements. At Boudreaux's New Drug Store, our philosophy is founded on the belief that every individual deserves access to comprehensive pharmaceutical care that goes beyond dispensing medication. We view pharmacy as the leader in correcting patients' well-being and their overall health. By integrating evidence-based and personalized medication, we believe that illnesses are curable based on one's determination and the help of medical professionals. Relationships and agreements with other health care professionals are entered into with the goal of improved patient outcomes. Areas of focus in pharmaceutical care will include but are not limited to, medication problem-solving, customized hormone replacement therapy for men and women, diabetes (shoe program), wound care, pain management, nutraceutical support, drug regimen reviews, and medication case management.

About the Role:

The Sterile Compounding Process and Validation Engineer plays a critical role in ensuring the safety, efficacy, and compliance of sterile pharmaceutical products. This position is responsible for developing, implementing, and validating sterile compounding processes in accordance with regulatory standards such as USP <797> , FDA guidelines, and cGMP requirements. The engineer will collaborate closely with cross-functional teams including quality assurance, manufacturing, and regulatory affairs to optimize sterile production workflows and maintain rigorous process controls. A key outcome of this role is to guarantee that all sterile compounding operations meet stringent quality and safety standards, minimizing contamination risks and ensuring patient safety. Additionally, the engineer will lead continuous improvement initiatives to enhance process efficiency and validation robustness within the sterile compounding environment.

Minimum Qualifications:

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Biomedical Engineering, or a related field.
• Minimum of 3 years of experience in sterile compounding process development and validation within a pharmaceutical or biotechnology environment.
• Strong knowledge of USP <797> , FDA regulations, and cGMP guidelines related to sterile manufacturing.
• Experience with process validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Proficiency in risk assessment methodologies and contamination control strategies.

Preferred Qualifications:

• Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline.
• Certification in sterile compounding or pharmaceutical quality systems (e.g., ASQ Certified Pharmaceutical GMP Professional).
• Experience with aseptic processing technologies and cleanroom environmental monitoring.
• Familiarity with electronic batch record systems and validation software tools.
• Strong project management skills and experience leading cross-functional teams.

Responsibilities:

• Design, develop, and validate sterile compounding processes to ensure compliance with regulatory and quality standards.
• Conduct risk assessments and process simulations to identify potential contamination sources and implement mitigation strategies.
• Prepare and review validation protocols, reports, and documentation related to sterile compounding processes.
• Collaborate with quality assurance and manufacturing teams to troubleshoot process deviations and implement corrective actions.
• Maintain up-to-date knowledge of industry regulations and best practices related to sterile compounding and incorporate them into process improvements.
• Lead training sessions for staff on sterile compounding procedures and validation requirements.
• Support internal and external audits by providing necessary documentation and process insights.

Skills:

The required skills enable the engineer to design and validate sterile compounding processes that comply with stringent regulatory standards, ensuring product safety and quality. Proficiency in risk assessment and contamination control is essential for identifying vulnerabilities and implementing effective mitigation strategies. Strong documentation and communication skills facilitate the preparation of validation protocols and collaboration with quality and manufacturing teams. Preferred skills such as experience with aseptic technologies and electronic validation tools enhance the ability to streamline processes and improve data accuracy. Additionally, project management and leadership skills support the coordination of validation activities and continuous improvement initiatives across departments.