Quality Assurance Engineer II - Process and Validation

Civica - Petersburg, VA

Full-time - Mid Level

Petersburg, VA

Professional, Scientific, and Technical Services

About the position

The Quality Assurance Engineer II will be responsible for ensuring compliance with quality systems and oversight at Civica's Petersburg, Virginia facility, which is dedicated to the manufacture and supply of essential generic sterile injectable medications. This role focuses on supporting product process validation, cleaning validation, and quality risk management to meet cGMP and Civica compliance requirements, ultimately leading to successful FDA approval of the facility and new 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.
• Lead or participate in Quality Risk Management and analysis.
• Maintain knowledge of local and international regulatory requirements to provide expert advice on quality matters.
• Support compliance of product process transfers, including validation, from/to other manufacturing sites.
• Lead activities related to product introduction to the site.
• Support aseptic process simulations.
• Support quality processes across the product lifecycle including change control, CAPA, deviations, and investigations.
• Provide quality review and support for laboratory method validation and LIMS.
• Proactively identify and resolve problems using risk-based approaches.
• Promote a quality and safety mindset in all operations activities.

Requirements

• Bachelor's degree in a scientific discipline.
• Minimum of 6 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.
• Strong project management, organization, and execution skills.
• Experience supporting regulatory agency inspections.
• Excellent interpersonal and written communication skills.

Nice-to-haves

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