Validation Engineer III 503B

Empower Pharmacy; Houston (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Join a visionary healthcare company as a Validation Engineer III, where you'll ensure regulatory compliance and drive innovation in medication accessibility. This role is pivotal in overseeing the validation of systems and processes, enhancing operational efficiency, and supporting regulatory audits. With a strong focus on quality and service, you'll collaborate with a dedicated team committed to making a difference in healthcare. If you're a forward-thinker ready to contribute to transformative projects in a supportive environment, this opportunity is for you.

Benefits

Medical Coverage

Dental Coverage

Vision Coverage

401(k) Matching

Paid Time Off

Wellness Perks

IV Therapy

Compounded Medications

Qualifications

• 10 years of validation experience in pharmaceutical or biotechnology industries.
• Strong knowledge in sterilization validation and CQV.

Responsibilities

• Oversee validation of systems, equipment, and processes.
• Manage Computer System Validation lifecycle and technical transfers.
• Lead continuous improvement initiatives in operational efficiency.

Skills

Good Manufacturing Practices

Computer System Validation

Project Management

Problem-Solving

Analytical Skills

Microsoft Office

Quality Management Systems

Education

Bachelor of Science in a scientific or engineering discipline

Job description

Location: Houston, Texas 77041, United States

Posted: May 2, 2025

Job Type: Full Time

Req# 4192

Quality

Company Overview

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.

Position Summary

The Validation Engineer III ensures regulatory compliance by overseeing the validation of systems, equipment, and processes while managing the full lifecycle of Computer System Validation and cross-functional projects. This role plays a critical part in driving technical transfers, optimizing validation strategies, and leading continuous improvement initiatives to enhance operational efficiency. Additionally, the Senior Validation Engineer supports regulatory audits and inspections, proactively identifying and mitigating compliance risks to uphold the highest industry standards.

Duties and Responsibilities

• Ensures compliance by validating facilities, equipment, systems, and processes while authoring and approving commissioning and validation documents for sterile and non-sterile manufacturing.
• Manages the lifecycle of Computer System Validation, executes multiple protocols, and analyzes data to create reports, including deviations.
• Coordinates cross-departmental validation activities, tracks timelines and budgets, and drives technical transfers across Empower sites.
• Leads continuous improvement through quality investigations, Corrective and Preventive Actions, Risk Assessments, Change Control, and staff training.
• Provides expertise during audits, manages contractors for Commissioning, Qualification, and Validation (CQV), and develops cleaning, sterilization, and process cycles.

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.

Knowledge and Skills

• Advanced knowledge in current good manufacturing practices, CQV, sterilization validation, Good Automated Manufacturing Practice, 21 Code of Federal Regulations Part 11, and experience with Computer System and Cleaning Validation.
• Strong project management, problem-solving, and analytical skills with attention to detail and proficiency in Microsoft Office and Quality Management Systems.

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.

Experience and Qualifications

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

Employee Benefits, Health, and Wellness

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/ - Link Opens in New Tab