Quality Engineer

Primary role is to supports manufacturing and quality operations to ensure compliance with cGMP, FDA, and applicable regulatory requirements. This role is responsible for maintaining and improving quality systems, supporting investigations and CAPAs, and partnering with cross-functional teams to ensure the consistent manufacture and release of high-quality pharmaceutical products.

Reports to the Quality Control Manager and supports the Quality Control organization. This role will interact with cross-functional departments including Manufacturing, Research and Development, Analytical Development, Quality Assurance, and Facilities, as well as external vendors and service providers, to support Quality Control operations, equipment, and quality system activities.

• 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.

• 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.

• Ability to stand for up to 8 hours per day.
• Frequent sitting, standing, walking, reading written documents and use of computer monitor screen, talking, writing, listening.
• Occasional climbing ladders/steps, walking up inclines and uneven terrain, reaching with hands and arms, stooping, kneeling, crouching, crawling, twisting, bending, handling, turning, balancing, carrying, grasping.
• Occasional lifting and/or moving up to 50 pounds.

This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin.

If you are interested in joining the Benuvia team, please SUBMIT YOUR RESUME below with your salary requirement.

Applicants must be legally authorized to work in the U.S. Visa sponsorship is not available at this time.

Positions posted for Benuvia Operation are not intended for or open to third party recruiters or agencies. Unsolicited resumes for these positions will be considered to be free referrals.