Pharmaceutical Packaging Equipment Engineer

Job Description
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 UserRequirements Specifications (URS) for packaging lines, including overallline requirements and individual equipment modification specifications.
• Develop andupdate packaging line layouts and equipment drawings for technical reviewand approval.
• Lead anddocument equipment design reviews as required.
• Coordinateequipment modifications, upgrades, and integration activities to supportnew product requirements and manufacturing operations.
• Manage OEMs andthird-party equipment vendors, including technical coordination,scheduling, onsite oversight, and deliverable tracking.
• Supportequipment installation, commissioning, and startup activities.

Equipment Documentation & Compliance

• Review, update,and develop Standard Operating Procedures (SOPs) as required to supportequipment modifications.
• Updateequipment manuals and technical documentation to reflect design changesand completed modifications.
• Coordinate andmaintain vendor documentation, including service reports, equipmentmanuals, and updated technical drawings.
• Supportequipment change control and risk assessment activities.
• Partner withValidation personnel to support validation planning, documentationdevelopment, and execution.

Testing & Equipment Acceptance

• Develop andexecute equipment acceptance test protocols in collaboration with projectand technical support personnel.
• Coordinatevendor and internal resources to complete equipment testing and verifyequipment functionality following modifications.
• Support theacceptance testing and implementation of new equipment, includingtamper-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 FillVision System: Integrate the existing gross fill vision system with the BFS trimdie to enable gross fill verification and automatic product rejection.
• MaterialHandling Systems: Modify material transfer and handling between thetrim die outfeed and Wilco leak detector infeed.
• Wilco LeakDetector: Modify equipment to accommodate new products, including automatedloading and unloading stations and required tooling changes.
• Doboy FoilPoucher: Modify existing foil pouching equipment to accommodate new productrequirements.
• Stream FeedCarton Feeding System: Support equipment modifications and integration.
• Checkweigher: Supportequipment integration and required modifications.
• SerializationStation: Support packaging line integration and serialization requirements.
• Tamper-EvidentSeal System: Potentially specify and procure new equipment for tamper-evidentseal application and verification.
• Zebra CaseLabel Printer: Support equipment integration and case labeling requirements.

Project Management & Coordination

• Contribute tothe development, coordination, and maintenance of project schedules.
• Track projectactivities, milestones, and deliverables.
• Provide regularproject status updates and communicate progress, issues, and potentialrisks.
• Coordinatevendor schedules and oversee onsite vendor activities.
• Track andreport individual project hours.
• Ensure vendordocumentation and equipment deliverables are completed and properlymaintained.
• Coordinate withinternal engineering, manufacturing, validation, and othercross-functional teams to support project execution.

Requirements

Qualifications & Requirements

Education

• Bachelor'sdegree in Mechanical Engineering, Electrical Engineering, or a relatedengineering discipline; equivalent relevant engineering experience willalso be considered.

Professional Experience

• Minimum of 5years of equipment engineering experience; 8-10 years preferred.
• Hands-onexperience with automated packaging equipment, equipment modifications,and manufacturing line integration.
• Experience withpackaging machinery such as pouching equipment, cartoners, labelingsystems, scanners, checkweighers, and automated vision inspection systems.
• Experienceworking in a cGMP-regulated manufacturing environment.
• Pharmaceuticalmanufacturing experience preferred; experience in food, cosmetics, orother regulated manufacturing industries will also be considered.
• Familiaritywith equipment change control, commissioning, acceptance testing, andvalidation support.
• Experiencecoordinating OEMs, equipment suppliers, and third-party engineeringvendors.
• LeanManufacturing, Six Sigma, or formal project management experience is aplus.

Knowledge, Skills & Abilities

• Strongmechanical aptitude and the ability to understand equipment functionality,modifications, and integration requirements.
• Ability tointerpret engineering drawings, equipment layouts, technicalspecifications, and operating manuals.
• Excellenttechnical writing, documentation, and organizational skills.
• Stronganalytical, troubleshooting, and problem-solving abilities.
• High attentionto detail and the ability to perform risk assessments and identifypotential equipment or operational issues.
• Effectivewritten and verbal communication skills, including the ability to interactdirectly with equipment manufacturers, vendors, internal management, andcross-functional teams.
• Ability tomanage multiple priorities and work independently while contributingeffectively in a team environment.
• Proficiencywith Microsoft Office applications, including Word and Excel.
• Familiaritywith cGMP principles, quality systems, and safe work practices.
• Demonstratedinitiative, accountability, and a proactive approach to resolvingtechnical challenges and driving project completion.