Process Engineer II - Sterile Injectables GMP Expansion

Civica; Petersburg (VA); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Civica is expanding its Petersburg, VA site and seeks a Senior Process Engineer II to bring the facility into production readiness and to support expansion for biologics. You will help design utilities, CIP/SIP capabilities, and high-speed cartridge filling lines while coordinating with Validation, Manufacturing and Quality Assurance.

The role requires hands-on involvement, strong technical acumen, and the ability to guide a growing organization through GMP startup, with collaboration across

Formación

• Bachelor’s degree in Engineering required.
• Strong mechanical aptitude.
• Demonstrated ability to solve technical problems and implement projects.
• Excellent interpersonal and communication skills, and fluency in English.
• Self-directed with effective analytical and problem-solving skills.
• Interact well with other functions and take ownership of projects with minimal supervision.
• Willingness to adapt to changing priorities as project demands change.

Responsabilidades

• Provide CQV expertise and ensure regulatory compliance and engineering standards.
• Participate in engineering to develop technical and procedural controls in design.
• Own CQV activities for assigned systems across phases: requirements, protocols, testing, release.
• Deliver engineering work on schedule, identify details, and manage risks.
• Anticipate gaps and drive improvements in facility/equipment design and processes.
• Lead cross-functional groups to resolve issues and drive DMAIC and FMEA initiatives.
• Communicate with vendors and internal teams to ensure availability and support.

Conocimientos

Fluency in English

Strong mechanical aptitude

Analytical problem-solving

Cross-functional collaboration

Self-directed

Educación

Bachelor’s degree in Engineering

Descripción del empleo

Civica is expanding its Petersburg, VA site and seeks a Senior Process Engineer II to bring the facility into production readiness and to support expansion for biologics. You will help design utilities, CIP/SIP capabilities, and high-speed cartridge filling lines while coordinating with Validation, Manufacturing and Quality Assurance.

The role requires hands-on involvement, strong technical acumen, and the ability to guide a growing organization through GMP startup, with collaboration across