Computer System Validation Engineer

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.  

What sets us apart is our relentless focus on four core values: People, Quality, Service and Innovation. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.  

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.  

As a Computer System Validation Engineer, you will ensure the reliability and compliance of systems like Empower3 and LabX, supporting Empower’s mission to produce life-saving medications. This role offers opportunities to lead projects, optimize systems, and impact health by improving access to affordable medicines.

• Oversees the validation of laboratory systems, such as Empower3 and LabX, ensuring compliance with Good Automated Manufacturing Practice (GAMP 5), U.S. Food and Drug Administration (FDA) data integrity requirements, and Title 21 of the Code of Federal Regulations Part 11 (21 CFR Part 11).
• Develops, executes, reviews, and summarizes Installation Qualification, Operational Qualification (OQ), and Performance Qualification protocols for computerized systems, adhering to both regulatory and internal quality standards.
• Leads Computerized Systems Validation projects, coordinating with Quality Operations, Quality Assurance, Quality Control, Information Technology, and Operations teams to ensure timely and compliant execution of tasks.
• Conducts risk assessments for laboratory systems using methodologies such as Failure Mode and Effects Analysis to enhance systems and meet regulatory compliance standards.
• Provides technical expertise during new system implementations and modifications, maintain validated statuses, and supports continuous improvement by optimizing laboratory and manufacturing systems validation processes.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

• Excellent organizational, problem-solving, and project management skills, with the ability to manage complex projects and collaborate effectively across multidisciplinary teams.
• Skilled in Empower3, LabX, Supervisory Control and Data Acquisition, and enterprise systems for Computerized Maintenance Management Systems, Quality Management Systems, Environmental Monitoring Systems, and Building Management Systems. Advanced knowledge of GAMP 5, FDA data integrity, 21 CFR Part 11, and validation principles, with strong regulatory compliance and Microsoft Office proficiency.

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

• Minimum of 5 years of experience in Computer Systems Validation (CSV), focusing on laboratory and manufacturing systems validation required.
• Bachelor of Science in a scientific or engineering discipline (or equivalent experience) required.

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/