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Project Engineer II at Qualdoc, LLC – Richmond, Virginia

Qualdoc, LLC
Richmond, Virginia, 23219, United States
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About This Position

Project Engineer II

Title: Project Engineer II
Location: Richmond, VA
Job Type: Direct Hire
Salary: Up to $105,000 (Depending on Experience)

About the Role

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.
Responsibilities
Technical & Project Execution
  • 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)
Project Management
  • 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
Cross-Functional Collaboration
  • 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
Compliance & Continuous Improvement
  • 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
Documentation & Training
  • 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
Qualifications
Education & Experience
  • Bachelor’s 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
Skills & Abilities
  • 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
  • Experience with CAD or similar design software preferred
  • Ability to lead cross-functional teams and influence stakeholders
What We Offer

Competitive salary and comprehensive benefits including Medical, Dental, Vision, Short and Long-Term Disability, Life and AD&D, 401(k), and more.

Job Location

Richmond, Virginia, 23219, United States

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