Process Validation Engineer II
7 days ago
About Civica Rx
Civica Rx is a forward-thinking organization committed to ensuring the accessibility and affordability of essential generic sterile injectable medications. Our team is dedicated to promoting a culture of excellence in quality and compliance, while providing life-saving medicines to those who need them most.
We are seeking a skilled Quality Assurance Engineer II to join our team at our Petersburg, Virginia site. In this role, you will be responsible for supporting our quality systems and oversight to ensure product process validation, cleaning validation, Quality Risk Management, and quality laboratory systems meet cGMP and regulatory requirements.
Your responsibilities will include:
- Supporting quality systems and oversight to ensure product process validation, cleaning validation, Quality Risk Management, and quality laboratory systems meet cGMP and regulatory requirements.
- Leading or participating in Quality Risk Management and analysis.
- Maintaining current knowledge of local and international regulatory and legislative requirements.
This is an exciting opportunity for a motivated individual to join our team and contribute to our mission of ensuring the accessibility and affordability of essential generic sterile injectable medications. The salary for this position is $105,000 - $125,000 per year, depending on experience.
Job Requirements:
- Bachelor's degree in a scientific discipline with a minimum of 6 years Quality/cGMP experience in the pharmaceutical industry.
- Experience in process and cleaning validation, LIMS systems, Aseptic Process Simulations, and Quality Risk Management.
- Knowledge in 21CFR Part 11, Electronic Records and Signatures, and data integrity.
Our Offer:
- Competitive salary range: $105,000 - $125,000 per year.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
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