Project Engineer II (Mid-Level)

Qualdoc•Richmond, VA

1d•$105,000

About The Position

The Project Engineer II will manage small- to large-scale packaging engineering projects within a cGMP and FDA-regulated manufacturing environment. This role focuses on packaging equipment design, selection, installation, and optimization. You will independently initiate, plan, and execute projects while contributing to more complex initiatives and collaborating cross-functionally to ensure equipment meets production, quality, cost, and compliance objectives.

Requirements

Bachelorâs degree in Mechanical Engineering or related field
5+ years of experience in a manufacturing environment (pharmaceutical, personal care, or similar preferred)
Experience with equipment design, installation, commissioning, and validation in a cGMP environment
Strong project management and organizational skills
Ability to manage multiple projects independently
Analytical, troubleshooting, and problem-solving skills
Effective communication and technical writing abilities
Working knowledge of FDA cGMP requirements
Ability to read and interpret P&IDs, process flow diagrams, and technical drawings

Nice To Haves

Experience with CAD or similar design software preferred
Ability to lead cross-functional teams and influence stakeholders

Responsibilities

Provide engineering support for packaging equipment projects for new and existing products
Design and develop packaging equipment lines and support systems integration
Lead or support installation, commissioning, and verification of equipment
Develop and execute equipment testing and qualification protocols
Assist with vendor testing, factory acceptance testing (FAT), and site acceptance testing (SAT)
Initiate, plan, and manage multiple projects simultaneously, including scope, schedule, and budget
Perform cost estimation and track project expenses
Support capital project planning, budgeting, and long-range planning initiatives
Conduct project status updates and present progress to stakeholders
Review and approve contractor bids, RFIs, and change requests
Work with Operations, Quality, Regulatory Affairs, Engineering, Purchasing, and vendors to resolve challenges
Coordinate multi-disciplinary teams to ensure successful project execution
Ensure alignment with site standards, best practices, and regulatory requirements
Ensure all activities comply with FDA cGMP and company policies
Support change control processes for new equipment and process changes
Manage or support equipment validation
Identify opportunities for process improvements and standardization
Promote and exemplify cGMP compliance in all activities
Prepare and maintain project documentation including SOPs, job aids, and technical reports
Maintain accurate project records and history files
Train production staff on new equipment and processes
Serve as a technical resource and mentor to junior team members