PCI Pharma Services · 2 days ago
Project Engineer II
Rockford, IL
Full-time
Onsite
Mid, Senior Level
$87K/yr - $103K/yr
5+ years expPCI Pharma Services is a global leader in contract packaging and manufacturing solutions focused on delivering life-changing therapies. As a Project Engineer II – Drug Delivery, you will lead complex technical projects supporting the development and commercialization of pharmaceutical packaging solutions while collaborating with various internal teams to ensure project success.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Hiring Manager
Shaniece Williams
Responsibilities
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
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
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
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
Qualification
Required
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
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
Benefits
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k)
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase