Pharmaceutical Packaging Equipment Engineer
Industry: Sterile Pharmaceutical Manufacturing
Location: Woodstock, IL – Onsite
Contract: 6+ months, with strong potential for extensions
Schedule: Full-time, approximately 40 hours per week
Position Summary:
Automated Systems, Inc. (ASI) is seeking an experienced Pharmaceutical Packaging Equipment Engineer to support capital projects and drive packaging equipment modifications, upgrades, and integration initiatives at our client's sterile pharmaceutical manufacturing facility in Woodstock, IL.
The facility is a contract manufacturer of sterile liquid pharmaceutical products, with primary manufacturing operations that include compounding, Blow-Fill-Seal (BFS), and secondary packaging, including serialization.
In this role, you will provide hands-on engineering and project coordination support throughout the equipment modification and implementation lifecycle. Responsibilities include developing User Requirements Specifications (URS), evaluating equipment requirements, coordinating OEM and third-party vendors, overseeing equipment modifications, supporting acceptance testing, and assisting with commissioning and validation activities.
The ideal candidate will have a strong mechanical and equipment engineering background, experience with automated packaging systems, and the ability to manage multiple equipment-related activities in a regulated manufacturing environment.
Key Responsibilities:
Packaging Equipment Engineering & Project Execution
- Develop User Requirements Specifications (URS) for packaging lines, including overall line requirements and individual equipment modification specifications.
- Develop and update packaging line layouts and equipment drawings for technical review and approval.
- Lead and document equipment design reviews as required.
- Coordinate equipment modifications, upgrades, and integration activities to support new product requirements and manufacturing operations.
- Manage OEMs and third-party equipment vendors, including technical coordination, scheduling, onsite oversight, and deliverable tracking.
- Support equipment installation, commissioning, and startup activities.
Equipment Documentation & Compliance
- Review, update, and develop Standard Operating Procedures (SOPs) as required to support equipment modifications.
- Update equipment manuals and technical documentation to reflect design changes and completed modifications.
- Coordinate and maintain vendor documentation, including service reports, equipment manuals, and updated technical drawings.
- Support equipment change control and risk assessment activities.
- Partner with Validation personnel to support validation planning, documentation development, and execution.
Testing & Equipment Acceptance
- Develop and execute equipment acceptance test protocols in collaboration with project and technical support personnel.
- Coordinate vendor and internal resources to complete equipment testing and verify equipment functionality following modifications.
- Support the acceptance testing and implementation of new equipment, including tamper-evident seal application and verification systems, if required.
Equipment & Systems Involved
The project will involve modifications, integration, and upgrades to existing pharmaceutical packaging and manufacturing equipment, including:
- BFS Gross Fill Vision System: Integrate the existing gross fill vision system with the BFS trim die to enable gross fill verification and automatic product rejection.
- Material Handling Systems: Modify material transfer and handling between the trim die outfeed and Wilco leak detector infeed.
- Wilco Leak Detector: Modify equipment to accommodate new products, including automated loading and unloading stations and required tooling changes.
- Doboy Foil Poucher: Modify existing foil pouching equipment to accommodate new product requirements.
- Stream Feed Carton Feeding System: Support equipment modifications and integration.
- Checkweigher: Support equipment integration and required modifications.
- Serialization Station: Support packaging line integration and serialization requirements.
- Tamper-Evident Seal System: Potentially specify and procure new equipment for tamper-evident seal application and verification.
- Zebra Case Label Printer: Support equipment integration and case labeling requirements.
Project Management & Coordination
- Contribute to the development, coordination, and maintenance of project schedules.
- Track project activities, milestones, and deliverables.
- Provide regular project status updates and communicate progress, issues, and potential risks.
- Coordinate vendor schedules and oversee onsite vendor activities.
- Track and report individual project hours.
- Ensure vendor documentation and equipment deliverables are completed and properly maintained.
- Coordinate with internal engineering, manufacturing, validation, and other cross-functional teams to support project execution.
Requirements
Qualifications & Requirements
Education
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related engineering discipline; equivalent relevant engineering experience will also be considered.
Professional Experience
- Minimum of 5 years of equipment engineering experience; 8–10 years preferred.
- Hands-on experience with automated packaging equipment, equipment modifications, and manufacturing line integration.
- Experience with packaging machinery such as pouching equipment, cartoners, labeling systems, scanners, checkweighers, and automated vision inspection systems.
- Experience working in a cGMP-regulated manufacturing environment.
- Pharmaceutical manufacturing experience preferred; experience in food, cosmetics, or other regulated manufacturing industries will also be considered.
- Familiarity with equipment change control, commissioning, acceptance testing, and validation support.
- Experience coordinating OEMs, equipment suppliers, and third-party engineering vendors.
- Lean Manufacturing, Six Sigma, or formal project management experience is a plus.
Knowledge, Skills & Abilities
- Strong mechanical aptitude and the ability to understand equipment functionality, modifications, and integration requirements.
- Ability to interpret engineering drawings, equipment layouts, technical specifications, and operating manuals.
- Excellent technical writing, documentation, and organizational skills.
- Strong analytical, troubleshooting, and problem-solving abilities.
- High attention to detail and the ability to perform risk assessments and identify potential equipment or operational issues.
- Effective written and verbal communication skills, including the ability to interact directly with equipment manufacturers, vendors, internal management, and cross-functional teams.
- Ability to manage multiple priorities and work independently while contributing effectively in a team environment.
- Proficiency with Microsoft Office applications, including Word and Excel.
- Familiarity with cGMP principles, quality systems, and safe work practices.
- Demonstrated initiative, accountability, and a proactive approach to resolving technical challenges and driving project completion.