Senior Process Engineer

2 weeks ago


Petersburg, United States Civica Rx Full time

About Civica:

Civica Rx is dedicated to addressing the critical shortages of generic injectable medications that have plagued hospitals across the United States for years. With over 300 essential medications currently in short supply, the organization is committed to reversing this trend.

Founded in 2018 by a coalition of health systems and philanthropic organizations, Civica aims to reduce the chronic shortages and high costs associated with generic drugs. Our mission is guided by the principle of prioritizing patient welfare above all else.

Today, Civica collaborates with more than 55 health systems, representing over 1,500 hospitals and a significant portion of U.S. hospital beds. Our efforts extend to supplying essential medicines to the U.S. Department of Veteran's Affairs and the U.S. Department of Defense.

As part of our commitment to making medications more affordable, Civica has launched CivicaScript, a sister organization focused on reducing the costs of high-priced generic drugs in the retail pharmacy market. Additionally, we are actively developing affordable biosimilar insulin to ensure consistent access for those in need.

Job Overview:
The Senior Process Engineer will be instrumental in preparing the Civica Petersburg, VA facility for production and in the design of facilities and equipment for our expansion into biologics.

Key Responsibilities:
- Oversee the establishment of a high-speed cartridge filling line and upgrades to critical utility services.
- Collaborate with cross-functional teams to ensure the facility meets Good Manufacturing Practices (GMP) standards.
- Act as the System Owner for manufacturing systems, ensuring their operational readiness and compliance throughout their lifecycle.

Essential Duties:
- Provide hands-on technical expertise during the Commissioning, Qualification, and Validation (CQV) phases.
- Develop and implement technical and procedural controls to enhance process design.
- Lead initiatives to identify and address operational gaps, ensuring a smooth transition to manufacturing operations.

Qualifications:
- Bachelor's degree in Engineering is required.
- A minimum of 5 years of experience in sterile injectables or biologics is preferred.
- Strong problem-solving skills and the ability to manage multiple complex projects in a fast-paced environment.

Join Civica Rx in our mission to improve patient access to essential medications and contribute to a transformative approach in the pharmaceutical industry.



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