Project Engineer- Drug Delivery

at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States Job Description Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Summary As a Project Engineer - Drug Delivery, you'll play a hands-on, critical role in the design, development, and execution of pharmaceutical packaging and assembly projects. Working closely with engineering, quality, and validation teams, you'll help deliver high-impact solutions that directly affect patient outcomes around the world. This role supports key product introductions - including high-speed auto-injector lines for diabetes management-giving you the opportunity to work on cutting-edge drug delivery technology. You'll collaborate with both internal stakeholders and external customers, ensuring projects are delivered on time, on budget, and in compliance with all regulatory standards. This is more than a role-it's a career path. Our Project Engineers have advanced to senior-level roles, including Engineering Manager, based on performance, innovation, and leadership. Key Responsibilities Project Execution & Engineering Design Design and implement line layouts for pharmaceutical assembly and packaging processes. Develop and procure tooling for new and existing packaging equipment to support clinical and commercial production. Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for packaging equipment. Drive equipment commissioning, qualification, and troubleshooting activities. Author and maintain engineering documentation including URS, SOPs, and validation support records. Technical Leadership & Innovation Apply engineering best practices to optimize process performance, safety, and product quality. Identify and resolve process inefficiencies with a focus on improving Overall Equipment Effectiveness (OEE). Participate in risk assessments and problem-solving investigations (e.g., CAPAs, root cause analysis). Lead line improvement initiatives using Lean Six Sigma and operational excellence tools. Client & Cross-Functional Collaboration Serve as a technical liaison with customers, sales, vendors, and internal stakeholders. Collaborate with Quality, Validation, Operations, and Business Development to support new product introductions and line extensions. Represent Engineering in weekly client meetings, cross-functional project updates, and design reviews. Support material selection and supplier communication to ensure packaging compatibility and performance. Compliance & Quality Support Ensure strict adherence to PCI's cGMP, GCP, and internal regulatory policies and procedures. Provide validation support through IQ/OQ/PQ processes. Review and approve batch records and technical documentation for accuracy and completeness. Qualifications Required: Bachelor's degree in Mechanical, Biomedical, Chemical, or related Engineering discipline. 1-5 years of experience in a project or process engineering role, ideally within the pharmaceutical or medical device industry. SolidWorks proficiency (required); AutoCAD experience a plus. Strong problem-solving and analytical skills with demonstrated attention to detail. Full professional fluency in English (written and verbal). Intermediate to advanced proficiency in Microsoft Office (Excel, Project, PowerPoint, Visio). College-level mathematical and technical reasoning skills. Preferred: Experience in medical device or pharmaceutical packaging equipment (e.g., blister, bottling, pouching, cartoning). Familiarity with cGMP regulations and cleanroom manufacturing environments. Knowledge of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971). Lean Six Sigma Green Belt certification or similar process improvement training. Demonstrated ability to collaborate across departments and communicate with external clients. Ability and willingness to travel based on project needs. The base salary hiring range for this position is ($77,600 - $92,150) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off,... For full info follow application link. LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company. To view full details and how to apply, please login or create a Job Seeker account