Process Engineer II - GMP Startup & Sterile Fill-Finish

BioSpace; Petersburg (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

Civica Petersburg, VA seeks a Senior Process Engineer II to bring a new facility expansion into production readiness, focusing on biologics, CIP/SIP utilities, and high-speed cartridge filling lines. This role will bridge project planning and operations, interfacing with Validation, Manufacturing and QA to ensure systems are reliable and compliant.

The candidate will lead cross-functional groups, apply problem-solving methods, and contribute to a culture of continuous improvement as the site

Qualifications

• Willingness to perform hands-on work in a dynamic, team-oriented setting.
• Ability to collaborate across Manufacturing, QA, R&D and external vendors.
• Experience applying DMAIC and FMEA for process improvement.
• Strong verbal and written communication skills in English.

Responsibilities

• Provide CQV-oriented technical leadership for assigned systems.
• Ensure regulatory compliance and industry best practices in process design.
• Develop technical and procedural controls during design and startup.
• Coordinate validation planning, protocols, tests, and system release.
• Collaborate with Validation, Manufacturing, Quality Assurance to sustain systems.

Skills

Hands-on work

Cross-functional collaboration

DMAIC & FMEA

Strong communication

Education

Bachelor’s degree in Engineering

Job description

Civica Petersburg, VA seeks a Senior Process Engineer II to bring a new facility expansion into production readiness, focusing on biologics, CIP/SIP utilities, and high-speed cartridge filling lines. This role will bridge project planning and operations, interfacing with Validation, Manufacturing and QA to ensure systems are reliable and compliant.

The candidate will lead cross-functional groups, apply problem-solving methods, and contribute to a culture of continuous improvement as the site