Process Engineer II

Job Description

Job Opening : Process Engineer II

📍 Location : Petersburg, VA

🕒 Full-Time | On-Site

Are you ready to make a meaningful impact in the world of biologics manufacturing? We’re seeking a Process Engineer II to help bring a cutting-edge facility into full GMP production. This is a unique opportunity to be part of a major expansion project, including high-speed cartridge filling, upgraded utilities, and advanced formulation suites with CIP / SIP capabilities.

As a key member of the startup team, you’ll help shape the systems, processes, and culture of a growing site. If you thrive in dynamic environments and enjoy hands-on engineering work, this role is for you.

What You’ll Do

Own and manage manufacturing systems from startup through lifecycle.

Lead CQV activities and ensure compliance with regulatory and engineering standards.

Collaborate across teams to design, validate, and optimize production processes.

Identify and resolve operational gaps to ensure smooth transition to manufacturing.

Drive continuous improvement using tools like DMAIC and FMEA.

Communicate effectively with internal teams and external vendors.

What You Bring

Required :

Bachelor’s degree in Engineering.

Strong mechanical aptitude and problem-solving skills.

Excellent communication and interpersonal abilities.

Ability to manage multiple complex projects in a fast-paced setting.

Self-directed and adaptable to changing priorities.

Preferred :

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

Expertise in drug product processing equipment (e.g., mixers, washers, autoclaves, aseptic filling systems).

Experience with capital equipment procurement and maintenance planning.

Familiarity with cleaning and process validation.

Background in greenfield or major facility expansion projects.