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Validation Engineer
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hims & hers Hims & Hers is a leading health and wellness platform dedicated to improving health outcomes through personalized care and innovative solutions. We are seeking a detail-oriented and compliance-focused Pharmaceutical Validation Engineer to support validation activities in our pharmacy facilities. This role involves ensuring systems, equipment, processes, and environments meet regulatory and operational standards, including hands-on experience with CQV, process and cleaning validation, and documentation in accordance with cGMP, USP, and FDA standards. Responsibilities include:
Developing and executing IQ, OQ, and PQ protocols for cleanrooms, HVAC, and equipment. Creating validation master plans, risk assessments, and documentation. Performing validation testing and analyzing data for compliance and improvements. Maintaining validation reports and supporting audits. Executing CQV for equipment and utilities, reviewing vendor documentation. Conducting process and cleaning validation, supporting CSV activities. Collaborating across teams to ensure compliance and training staff. Participating in continuous improvement initiatives. Qualifications:
Bachelor’s degree in Engineering or a related science discipline. 5+ years in validation or pharmaceutical manufacturing, with knowledge of USP, cGMP, and FDA regulations. Experience in creating and executing validation protocols and risk assessments. Familiarity with validation of utilities, cleanrooms, and automation systems. Proficiency in Microsoft Office, AutoCAD, and validation documentation systems. Strong analytical and communication skills, with leadership abilities. Benefits include:
Competitive salary and equity. Unlimited PTO, health benefits, and employee stock purchase. Retreats, 401k, and a diverse, inclusive culture. If you're excited about this role, we encourage you to apply. Hims & Hers is committed to diversity, equity, and inclusion, and provides accommodations for applicants with disabilities.
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Validation Engineer
role at
hims & hers Hims & Hers is a leading health and wellness platform dedicated to improving health outcomes through personalized care and innovative solutions. We are seeking a detail-oriented and compliance-focused Pharmaceutical Validation Engineer to support validation activities in our pharmacy facilities. This role involves ensuring systems, equipment, processes, and environments meet regulatory and operational standards, including hands-on experience with CQV, process and cleaning validation, and documentation in accordance with cGMP, USP, and FDA standards. Responsibilities include:
Developing and executing IQ, OQ, and PQ protocols for cleanrooms, HVAC, and equipment. Creating validation master plans, risk assessments, and documentation. Performing validation testing and analyzing data for compliance and improvements. Maintaining validation reports and supporting audits. Executing CQV for equipment and utilities, reviewing vendor documentation. Conducting process and cleaning validation, supporting CSV activities. Collaborating across teams to ensure compliance and training staff. Participating in continuous improvement initiatives. Qualifications:
Bachelor’s degree in Engineering or a related science discipline. 5+ years in validation or pharmaceutical manufacturing, with knowledge of USP, cGMP, and FDA regulations. Experience in creating and executing validation protocols and risk assessments. Familiarity with validation of utilities, cleanrooms, and automation systems. Proficiency in Microsoft Office, AutoCAD, and validation documentation systems. Strong analytical and communication skills, with leadership abilities. Benefits include:
Competitive salary and equity. Unlimited PTO, health benefits, and employee stock purchase. Retreats, 401k, and a diverse, inclusive culture. If you're excited about this role, we encourage you to apply. Hims & Hers is committed to diversity, equity, and inclusion, and provides accommodations for applicants with disabilities.
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