Project Engineer III

PCI Pharma ServicesRockford, IL
Onsite

About The Position

As a Project Engineer III – Drug Delivery, you will lead the execution of high-impact engineering projects supporting the development and commercialization of pharmaceutical products. This is a highly visible role that combines deep technical expertise with project leadership, requiring close collaboration with internal and external stakeholders. You will play a pivotal role in the industrialization of combination drug delivery systems, including auto-injectors used in diabetes management—cutting-edge technologies that directly impact patient outcomes and global health. You’ll also mentor junior engineers and serve as a key technical interface for global partners, ensuring every project is delivered with precision, innovation, and speed. You’ll be part of a tight-knit, cross-functional team that values collaboration, open communication, and giving every team member a voice throughout the planning and execution phases. This is more than a role—it’s a career path, with our Project Engineers being promoted to senior-level Project Engineering positions including Project Engineering Manager positions.

Requirements

  • Bachelor’s degree in Mechanical, Electrical, Chemical, Biomedical Engineering, or related field.
  • 10+ years of experience in project engineering, manufacturing, and device design in regulated industries.
  • Strong understanding of product design, process optimization, and risk mitigation strategies.
  • Excellent communication skills (verbal and written) with the ability to lead and influence.
  • Proficiency in MS Project, AutoCAD, SAP, Excel, and other project management tools.
  • Proven ability to manage multiple priorities in a dynamic environment.

Nice To Haves

  • PMP or PE certification or similar project management credential.
  • Lean Six Sigma certification or equivalent process improvement training.
  • Familiarity with combination products or medical device packaging equipment.
  • Certifications in cGMP, LEED, OSHA, or related disciplines.

Responsibilities

  • Lead complex engineering projects from initiation through completion, ensuring alignment with quality, cost, and delivery goals.
  • Manage project plans, scopes, timelines, and budgets, ensuring execution excellence at every step.
  • Coordinate with vendors and review project documentation to ensure timely completion and compliance with specifications.
  • Lead projects involving high-speed assembly and packaging of combination medical devices, including auto-injectors.
  • Oversee design transfer and industrialization of drug delivery platforms, ensuring smooth scale-up to commercial production.
  • Apply engineering best practices to optimize manufacturability, reliability, and regulatory compliance.
  • Conduct risk assessments (e.g., FMEA, pFMEA) and lead process improvement initiatives across the product lifecycle.
  • Serve as a mentor to Project Engineers I and II, contributing to a culture of growth and continuous improvement.
  • Act as a technical subject matter expert with customers, regulatory stakeholders, and contractors.
  • Collaborate with Quality, Validation, Manufacturing, and Business Development to ensure cross-functional success.
  • Lead client-facing meetings, ensuring PCI’s engineering efforts align with evolving partner expectations.
  • Contribute to engaging, transparent discussions during project planning and execution—your voice matters here.
  • Ensure full compliance with all PCI policies and relevant regulations including 21 CFR Part 820, ISO 13485, ISO 11608, and ISO 14971.
  • Lead efforts to implement corrective actions and troubleshoot technical issues.
  • Utilize Lean Six Sigma and operational excellence methodologies to drive efficiency and quality.

Benefits

  • paid time off
  • health insurance coverage (including dental and vision)
  • flexible spending account
  • 401(k)
  • eligibility for an annual performance bonus
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