Validation Specialist

Atilar Pharma | Houston, Texas | Full-Time About Atilar Pharma Atilar Pharma is a 503B outsourcing facility dedicated to producing compounded sterile preparations that meet the highest standards of pharmaceutical quality, safety, and regulatory compliance. As a growing organization built on precision and patient safety, we combine rigorous cGMP practices with a collaborative, quality-driven culture. Joining our team means contributing directly to work that supports better patient outcomes—and doing it alongside professionals who take pride in getting the details right. The Role We are seeking an experienced and highly skilled Validation Specialist to join our growing operations team. In this role, you'll serve as a subject matter expert in validation and qualification activities, taking ownership of critical programs that ensure our compounded sterile preparations meet all applicable USP, FDA, and cGMP requirements. If you're a seasoned validation professional eager to make a meaningful impact at a facility built on precision and patient safety, we encourage you to apply. Responsibilities Lead the planning, execution, and documentation of validation and qualification activities, including IQ, OQ, and PQ for equipment, facilities, utilities, and manufacturing processes. Author, review, and approve validation protocols, reports, SOPs, and other controlled documents in accordance with cGMP and 503B regulatory standards. Own cleaning validation and process validation programs for sterile compounding operations from inception through approval. Drive the qualification of HVAC systems, cleanrooms, autoclaves, filling equipment, and other critical facility systems. Serve as a cross-functional resource for Quality Assurance, Operations, and Pharmacy teams, providing validation expertise to support production timelines and regulatory readiness. Lead investigations into validation deviations and out-of-specification results, conducting root cause analyses and driving CAPA development and closure. Develop and maintain the Validation Master Plan and ensure all validation life cycle documentation is current, complete, and inspection-ready. Serve as a primary point of contact during internal audits, FDA inspections, and state board of pharmacy reviews for all validation-related matters. Mentor junior team members and contribute to building a robust validation program as the facility scales toward full commercial operations. Stay current with evolving FDA guidance, USP , USP , and other applicable standards, proactively incorporating updates into validation programs. Qualifications Minimum of 3 years of pharmaceutical validation experience. Deep working knowledge of USP , USP , FDA 503B guidance, and cGMP regulations (21 CFR Parts 210/211). Proven track record authoring, executing, and approving IQ/OQ/PQ protocols and cleaning and process validation studies. Extensive experience with cleanroom standards, environmental monitoring programs, and aseptic processing practices. Demonstrated ability to lead validation projects independently from initiation through regulatory approval. Strong analytical and problem-solving skills with exceptional attention to detail and documentation practices. Excellent written and verbal communication skills, with the ability to produce clear, audit-ready validation documentation and present findings to senior leadership. Experience supporting FDA inspections or regulatory audits in a validation capacity is strongly preferred. Strong organizational skills with the ability to manage multiple high-priority projects and deadlines simultaneously. Commitment to patient safety, regulatory compliance, and a culture of continuous quality improvement. We offer a comprehensive benefits package, including: 401(k) with company matching Health, dental, and vision insurance Health savings account (HSA) and flexible spending account (FSA) Paid time off Parental leave How to Apply If you meet the requirements and are interested in joining the Atilar Pharma team, please submit your resume and cover letter. #J-18808-Ljbffr