Your telehealth solution for better health
Hims & Hers is a multi-specialty telehealth platform headquartered in the Marina District of San Francisco, CA. The company provides accessible healthcare solutions for men and women, including products for skin care, birth control, erectile dysfunction, and hair loss. With over 1,000 employees and ...
Hims & Hers offers generous PTO, including parental leave, comprehensive healthcare coverage for individuals and families, and a 401(k) plan with cont...
Hims & Hers fosters an open and honest culture focused on accessibility and care. By combining telemedicine with a strong branding strategy, the compa...
Hims & Hers • New Albany, Ohio
Hims & Hers is seeking a Validation Engineer to support validation activities across compounding operations. You'll ensure compliance with regulatory standards and work with cGMP and FDA guidelines. This role requires hands-on experience in validation processes.
You are a detail-oriented and compliance-focused Pharmaceutical Validation Engineer with a strong background in validation activities across sterile and non-sterile compounding operations. You have hands-on experience with commissioning and qualification (CQV), process and cleaning validation, and equipment/system lifecycle documentation. Your expertise includes working in accordance with regulatory standards such as cGMP, USP <795>, <797>, <800>, and FDA 21 CFR Part 210/211. You understand the importance of ensuring that all systems, equipment, processes, and environments perform reliably and consistently. You are committed to delivering high-quality results and have a keen eye for detail, ensuring compliance with operational standards.
In this role, you will support validation activities across our 503A and 503B pharmacy facilities, ensuring that all operations meet regulatory and operational standards. You will be responsible for developing and executing validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). You will also conduct risk assessments and ensure that all documentation is maintained in accordance with regulatory requirements. Collaborating with cross-functional teams, you will provide validation support for new equipment and processes, ensuring that they are compliant with industry standards. You will participate in audits and inspections, providing necessary documentation and evidence of compliance. Your role will involve continuous improvement initiatives to enhance validation processes and ensure the highest quality standards are met.
At Hims & Hers, we offer a dynamic work environment where you can thrive and grow your career. We provide competitive compensation and a comprehensive benefits package that supports your health and well-being. Our culture is centered around innovation and collaboration, allowing you to contribute to meaningful projects that impact the health and wellness of our customers. We encourage you to apply even if your experience doesn't match every requirement, as we value diverse perspectives and backgrounds. Join us in our mission to redefine healthcare and make better health outcomes easier to achieve.
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