Process Engineer II (238)

The Process Engineer II will play a critical role in bringing the Civica Petersburg, VA facility into a production-ready state, and in facility and equipment design through commercialization for a newly announced facility expansion for biologics. Scope for the expansion includes a dedicated high-speed cartridge filling line, substantial upgrade to critical utilities services, and dedicated formulation and processing suites with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities.

In the project delivery and startup phase of the project (currently in progress through 2025), the

Senior Process Engineer will be dynamic as we endeavor to support the startup, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.

The Senior Process Engineer will act as a bridge between the project planning phase and ongoing operations by assuming System Owner responsibility for one or more manufacturing systems. In this role, the successful candidate will work closely with Validation, Manufacturing, and Quality Assurance to ensure availability, support, and maintenance of those system(s) throughout their lifecycle, and serve as subject matter expert internally and in regulatory inspections for production processes utilizing those systems.

5+ years of experience in sterile injectables, drug-device combination products, or biologics.

SME-level knowledge of drug product processing equipment (e.g. single-use mixers and stainless steel formulation vessels, parts washers, autoclaves, component processors, aseptic filling equipment – vials, pre-filled syringes, and cartridges – isolators with VPHP decontamination, filter integrity and isolator glove integrity testers).

Direct experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.

Familiarity with cleaning validation and/or process validation.

Previous work at greenfield sites or substantial facility expansion projects.