Process Engineer II

1w1 week ago

Civica Rx

Petersburg, US · Full-time · $95,000 – $125,000

About this role

Civica addresses critical shortages of essential generic injectables in U.S. healthcare. The Process Engineer II plays a critical role in bringing the Petersburg, VA facility into a production-ready state and supporting biologics expansion. Scope includes high-speed cartridge filling line, critical utilities upgrades, and CIP/SIP suites.

In the project delivery and startup phase through 2025, support facility startup and build a new organization. Develop and implement systems and business processes required for GMP operations. Foster site culture through collaboration, creativity, and resilience as the site scales.

Act as a bridge between project planning and ongoing operations by assuming System Owner responsibility for manufacturing systems. Work closely with Validation, Manufacturing, and Quality Assurance teams. Ensure system availability, support, and maintenance throughout the lifecycle.

Serve as subject matter expert internally and during regulatory inspections for production processes. Join Civica's mission to prevent drug shortages and provide affordable medicines. Contribute to a market-based nonprofit backed by health systems serving one-third of U.S. hospital beds.

Requirements

Experience in pharmaceutical process engineering for sterile injectables or biologics
Knowledge of GMP operations and startup of manufacturing facilities
Familiarity with high-speed cartridge filling lines and critical utilities
Expertise in CIP and SIP capabilities for formulation and processing suites
Background in validation, quality assurance, and system ownership in pharma
Ability to collaborate in dynamic environments during facility scaling

Responsibilities

Play a critical role in bringing the Civica Petersburg facility into a production-ready state
Support facility and equipment design through commercialization for biologics expansion
Support startup, build new organization, and develop systems for GMP operations
Act as a bridge between project planning phase and ongoing operations
Assume System Owner responsibility for one or more manufacturing systems
Work closely with Validation, Manufacturing, and Quality Assurance
Ensure availability, support, and maintenance of systems throughout their lifecycle
Serve as subject matter expert for production processes in regulatory inspections

Benefits

Join a mission-driven nonprofit preventing drug shortages for patients
Work in a new 140,000 sq ft state-of-the-art manufacturing facility
Contribute to supplying essential medicines to hospitals and government stockpiles