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Civica Rx

Validation Engineer II (377)

Petersburg, VA · On-site

Position Summary Validation Engineer II will be responsible for leading the commissioning, qualification, and validation (CQV) for a newly announced facility expansion for biologics that includes a ...

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What is it like to work at Civica Rx?

Civica Rx is a mission-driven organization that prioritizes collaboration, transparency, and a patient-centered approach to pharmaceutical manufacturing. The company operates with a lean and agile structure, fostering a dynamic work environment where employees from various disciplines work together to develop and manufacture essential medicines. Working at Civica Rx may appeal to candidates who are passionate about improving healthcare access and are motivated by the opportunity to contribute to a socially responsible and innovative organization.
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Infographic showing various job openings at Civica Rx in the United States as of June 2026, with employment types broken down into 50% Full Time, and 50% Nights. Highlights an 100% Physical job distribution.

Senior Scientist - Biologics

Civica Rx

Petersburg, VA • On-site, Remote

$89K - $122K/yr

Full-time

Posted 25 days ago

Job description

Job Description:

Our Biologics Development team brings essential biosimilar medicines to our patients in the United States by providing analytical expertise in developing protein bioassays, interpreting data, and assuring a thorough analytical package for health authority review. The Senior Scientist will bring their knowledge and experience in service to patients and pursuit of excellence to secure low cost insulins to patients within the United States.

The Senior Scientist Biologics will:

• Technical Lead and SME for de novo method development and characterization based on protein structure and biochemistry Provide strategic and scientific direction for phase-appropriate, biologics-specific assays Oversee microbiological testing strategy, including compendial method verification (endotoxin, bioburden, sterility), and ensures methods are suitable for the product

• Critically review and approve bioassay protocols; provide scientific direction and interpretation of data to drive next steps

• Provide scientific review of protocols, reports, and methods; establish clear technical expectations and guidance documents.

• Author specialized, preformatted, facility sections to create a facility core dossier

• Act as SME in regulatory interactions, including FDA meetings and inspections; defend bioassay and biological methods, based on Protein Chemistry

• Lead and conduct activities or projects as assigned

This role offers a flexible remote work style with travel to Civica’s Petersburg, Virginia manufacturing facility and Lehi, Utah office as needed.

Basic Qualifications and Capabilities:

We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue doing what is in the best interest of our patients.

What we look for:

• A Bachelors Degree in biochemistry with at least 5+ years of directly relevant professional experience in protein structure and functional assays

• Demonstrated organizational leadership skills at functional levels

• Application of sound and accurate judgment to make timely decisions

• Excellent strategic acumen, collaboration, and communication skills are required

• Excellent interpersonal, verbal, and written communication skills

Physical Demands and Work Environment:

• Ability to travel in the U.S. and internationally, as needed, for contract manufacturing oversight and Civica manufacturing site. Travel of up to 10% may be required

About Civica Rx

Sourced by ZipRecruiter

Industry

Pharmaceutical and medicine manufacturing

Company size

51 - 200 Employees

Headquarters location

Lehi, UT, US

Year founded

2018

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