Project Engineer II

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. As a Project Engineer II - Drug Delivery at PCI Pharma Services, you will take ownership of complex technical projects that directly support the development, scale-up, and commercialization of pharmaceutical packaging solutions. You will contribute to the engineering design, validation, and execution of high-impact packaging equipment and process initiatives across multiple value streams. You'll collaborate with internal stakeholders across Engineering, Quality, Validation, Operations, and Sales to ensure the success of new product introductions and process optimization projects. This is more than a role-it's a career path. At PCI, Project Engineers are given opportunities to grow into senior technical or people leadership roles. Several team members have been promoted into Engineering Manager roles from this track.Key Responsibilities Project Execution & Equipment Engineering Lead the specification, procurement, and commissioning of pharmaceutical manufacturing and packaging equipment. - Author technical documentation, including User Requirement Specifications (URS), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT). - Manage Capital Equipment Requests (CERs), including cost justification, budgeting, and timeline oversight. - Oversee the equipment acquisition and installation process in accordance with SOPs. - Use tools such as Design of Experiments (DOE) to optimize performance and validate results. Process Improvement & Technical Leadership - Serve as engineering subject matter expert across multiple packaging value streams. - Lead product launches, ensuring equipment readiness and process capability. - Identify and resolve process inefficiencies, focusing on Overall Equipment Effectiveness (OEE), defect reduction, and waste elimination. - Lead root cause investigations, Corrective and Preventive Actions (CAPAs), and continuous improvement using Lean and Six Sigma methodologies. Cross-Functional Collaboration - Act as the technical liaison with clients during audits, meetings, and new product discussions. - Collaborate with Sales and Business Development teams to define packaging and equipment needs. - Provide engineering training and develop SOPs, production line layouts, and visual diagrams. Compliance, Documentation & Validation - Support Validation during OQ and PQ for new business. - Conduct and document engineering investigations and manage change control processes. - Ensure strict adherence to all cGMP and FDA regulations and internal quality systems.Required Qualifications - Bachelor's degree in Mechanical, Biomedical, Chemical, or related Engineering discipline. - 5-10 years of engineering or project management experience in a regulated manufacturing environment. - Strong understanding of Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971). - High proficiency in data analysis, problem-solving, and process optimization. - Strong verbal and written communication skills. - College-level mathematical skills. - Full professional proficiency in English. - Advanced reasoning and decision-making abilities.Preferred Qualifications - Experience with pharmaceutical or medical device packaging equipment (e.g., blister, pouch, bottling, cartoning). - Familiarity with cGMPs and pharmaceutical manufacturing environments. - Skilled in Microsoft Office Suite, Microsoft Project, Visio, and AutoCAD. - Proven experience leading cross-functional project teams and working with clients. - Lean Six Sigma Green Belt or Black Belt certification a plus.Physical & Work Environment Requirements - Work is performed primarily in an office setting, with occasional time spent in a manufacturing or cleanroom environment. - Moderate physical activity required, including moving up to 50 pounds occasionally. - Must be comfortable working in areas requiring PPE. - Vision requirements include close vision.Why Join PCI? At PCI, you'll join a mission-driven company focused on delivering life-changing therapies to patients worldwide. As a global leader in contract packaging and manufacturing solutions, we offer a collaborative, fast-paced... 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