Quality Assurance Engineer - Process and Validation

Civica - Petersburg, VA

Full-time - Mid Level

Petersburg, VA

51-100 employees

Professional, Scientific, and Technical Services

About the position

The Quality Assurance Engineer at Civica will play a crucial role in supporting quality systems and oversight to ensure compliance with cGMP and FDA requirements during the construction and operation of a new manufacturing facility. This position involves validating processes, managing quality risks, and ensuring the introduction of new medications aligns with regulatory standards. The engineer will work collaboratively with various teams to promote a culture of quality and safety, ultimately contributing to Civica's mission of providing affordable medications.

Responsibilities

• Support quality systems and oversight to ensure product process validation and cleaning validation meet cGMP and Civica compliance requirements.
• Generate, review, and approve policies, procedures, reports, and records necessary for quality oversight.
• Work with validation and engineering teams to provide quality oversight for validation and qualification activities.
• Participate in Quality Risk Management and analysis.
• Maintain knowledge of local and international regulatory requirements to provide expert advice on quality matters.
• Support product process transfers and activities related to product introduction to the site.
• Support aseptic process simulations and quality processes across the product lifecycle.
• Provide quality review and support for laboratory method validation and LIMS.
• Support equipment, facilities, and utilities qualification as needed.
• Promote a quality mindset and safety focus in all operations.

Requirements

• Bachelor's degree in a scientific discipline.
• 4+ years of Quality/cGMP experience in the pharmaceutical industry.
• Experience in process and cleaning validation, LIMS systems, and Aseptic Process Simulations.
• Knowledge of 21CFR Part 11, Electronic Records and Signatures, and data integrity.
• Experience in leading activities to support regulatory agency inspections.
• Strong project management, organization, and execution skills.
• Excellent interpersonal and written communication skills.

Nice-to-haves

• Technical expertise in sterile pharmaceutical isolator technology, combination products, and medical devices.

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Professional development opportunities