Process Engineer II — GMP Biologics & Sterile Fill

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

Job summary

Civica Petersburg, VA is expanding its state-of-the-art manufacturing facility to bring sterile injectable products to GMP readiness and ongoing operations. The Senior Process Engineer will bridge project planning and manufacturing, ensuring systems are validated and maintained through scale-up.

Responsibilities include CQV execution, collaboration with Validation, Manufacturing, and Quality Assurance, and leading cross-functional teams to deliver robust system performance and regulatory

Qualifications

• Bachelor’s degree in Engineering is required.
• Strong mechanical aptitude and problem-solving skills.
• Excellent interpersonal and communication skills, fluent in English.
• Self-directed with ability to deliver results on multiple complex tasks.
• Ability to work with Manufacturing, Automation, Quality Assurance and R&D.
• Willingness to adapt to changing priorities.

Responsibilities

• Perform hands-on work in a team setting.
• Provide technical expertise on CQV activities and regulatory compliance.
• Develop and institute process controls in design.
• Own CQV activities for assigned systems across lifecycle.
• Deliver engineering outputs on schedule, manage risks.
• Lead cross-functional groups to drive improvements using DMAIC/FMEA.
• Communicate with system vendors and internal teams.

Skills

Engineering

Mechanical aptitude

Problem solving

Communication

English fluency

Cross-functional teamwork

Education

Bachelor’s degree in Engineering

Job description

Civica Petersburg, VA is expanding its state-of-the-art manufacturing facility to bring sterile injectable products to GMP readiness and ongoing operations. The Senior Process Engineer will bridge project planning and manufacturing, ensuring systems are validated and maintained through scale-up.

Responsibilities include CQV execution, collaboration with Validation, Manufacturing, and Quality Assurance, and leading cross-functional teams to deliver robust system performance and regulatory