PCI Pharma Services
Project Engineer- Drug Delivery
PCI Pharma Services, Rockford, Illinois, United States, 61103
Overview
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. You’ll work with engineering, quality, and validation teams to deliver high-impact solutions that affect patient outcomes. The role supports key product introductions including high-speed auto-injector lines for diabetes management, collaborating with internal stakeholders and external customers to ensure on-time, on-budget delivery in compliance with regulatory standards. This position offers a clear career path with opportunities for advancement based on performance and leadership. Responsibilities
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. 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. 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. 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, carting). 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. Salary and Benefits
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 factors including experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance (including dental and vision), flexible spending account, and 401(k). Equal Opportunity
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. We are committed to an inclusive workplace and equal opportunity for all employees.
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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. You’ll work with engineering, quality, and validation teams to deliver high-impact solutions that affect patient outcomes. The role supports key product introductions including high-speed auto-injector lines for diabetes management, collaborating with internal stakeholders and external customers to ensure on-time, on-budget delivery in compliance with regulatory standards. This position offers a clear career path with opportunities for advancement based on performance and leadership. Responsibilities
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. 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. 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. 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, carting). 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. Salary and Benefits
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 factors including experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance (including dental and vision), flexible spending account, and 401(k). Equal Opportunity
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. We are committed to an inclusive workplace and equal opportunity for all employees.
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