Benuvia Operations, LLC. · 4 hours ago
Quality Engineer
Round Rock, TX
Full-time
Onsite
Senior Level
5+ years expBenuvia is a company focused on maintaining high-quality pharmaceutical products. The Quality Engineer role involves supporting manufacturing and quality operations to ensure compliance with cGMP, FDA, and other regulatory requirements, while also maintaining quality systems and collaborating with cross-functional teams.
HealthcareManufacturingPharmaceuticalMedical
No H1B
Hiring Manager
Gina Amaya, PHR, SHRM-CP
Responsibilities
Author, execute, and maintain equipment qualification protocols and reports (IQ/OQ/PQ as applicable) in support of Quality Control laboratory operations
Author, execute, and maintain cleaning validation protocols and reports for equipment and laboratory areas, ensuring compliance with cGMP and internal requirements
Support the Quality Control organization in the management of quality system records, including change controls, CAPAs, deviations (DEVs), and out-of-specification (OOS) investigations, ensuring timely, thorough, and compliant documentation
Participate in and support root cause investigations, risk assessments, and the development of effective corrective and preventive actions
Coordinate with internal stakeholders and external vendors to ensure laboratory equipment calibration activities are completed accurately and within required timelines
Develop, revise, and maintain SOPs, work instructions, and processes related to equipment qualification, validation, calibration, and quality systems
Provide quality engineering support to operations to maintain a state of control and readiness for internal, client, and regulatory inspections
Review and assess the impact of proposed changes on systems, equipment, and processes, and support implementation through the change control process
Ensure documentation and activities comply with cGMP, FDA regulations, data integrity principles, and company policies
Collaborate cross-functionally with Quality Assurance, Manufacturing, R&D, Analytical development, and other stakeholders as required to support company objectives
Identify opportunities for process improvement within quality systems and contribute to continuous improvement initiatives
Qualification
Required
Bachelor's degree or higher in a life or chemical science; chemical engineer, chemistry, analytical chemistry, or a similar science-based degree preferred
Minimum of five years of experience in Quality Control within a pharmaceutical, chemical, or manufacturing environment, with at least two years of experience in a validation or quality engineering role
Strong knowledge of cGMP, FDA, ICH, and USP requirements
Hands-on experience with analytical techniques
Strong technical writing skills with a quality-oriented mindset, and a proven ability to author and execute protocols in laboratory and manufacturing environments
Strong interpersonal skills, with a demonstrated ability to work effectively, professionally, and respectfully in a team-based environment, and to collaborate with peers, customers, line management, and technical subject matter experts
Company
Benuvia Operations, LLC.
Benuvia Manufacturing is a leading developer and manufacturer of high-purity, pharmaceutical cannabinoid ingredients and products.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase