Validation Engineer II 503B

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.  

The Validation Engineer II ensures compliance and operational excellence by managing validation processes across sterile and non-sterile manufacturing. It oversees multiple projects, develops documentation, and collaborates with teams to enhance efficiency, support product development, and drive continuous improvement aligned with Empower’s mission to provide high-quality, accessible medications.

• Manages the full lifecycle of Computer System Validation, qualifying facilities, equipment, and processes, and developing key validation documentation, including Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, Performance Qualification, and Process Qualification for sterile and non-sterile manufacturing.
• Oversees multiple validation projects, ensuring timely budget-compliant completion while driving continuous improvement to boost manufacturing efficiency.
• Prepares, reviews, and approves technical documents, including Standard Operating Procedures and current Good Manufacturing Practice (cGMP) records, while managing change control, Corrective and Preventive Action, and quality investigations.
• Operates and manages critical equipment, executing cleaning, sterilization, and lyophilization cycles.
• Provides training, supports Research and Development and product development, manages contractors for Commissioning, Qualification, and Validation (CQV) activities, and assists with audits to ensure compliance.

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.

• Advanced knowledge of cGMP, CQV, sterilization process validation, and regulatory compliance, including Good Automated Manufacturing Practice and 21 Code of Federal Regulations Part 11.
• Strong problem-solving, project management, and attention to detail, with proficiency in Microsoft Office Suite, Quality Management Systems, and experience in Computer System Validation and Cleaning Validation preferred.

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.

• Bachelor of Science degree in a scientific or engineering discipline.
• 7 years Validation experience in the pharmaceutical or biotechnology industries.
• Certified Quality Engineer Preferred.

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/