Note: This position is open exclusively to candidates currently enrolled in the Hiring Our Heroes Fellows Program. Applications from individuals not participating in the program will not be considered.
Position Summary
The Engineer I is responsible for supporting the reliability, compliance, and continuous improvement of manufacturing systems, packaging automation, computerized systems, and IT infrastructure that support GMP operations. The role provides technical support for manufacturing processes, secondary packaging operations, automated inspection systems, labeling technologies, and business applications while ensuring assigned systems remain qualified, compliant, and inspection ready throughout their lifecycle.
The Engineer I serves as the System Owner for assigned assets and computerized systems, supporting engineering activities related to system reliability, lifecycle management, validation, change control, and operational excellence. The position collaborates closely with Quality, Manufacturing, Automation, Maintenance, Supply Chain, Information Systems, and Project teams to execute engineering activities in accordance with applicable regulatory requirements, corporate standards, and business objectives.
Key Responsibilities
System Ownership
- Serve as the System Owner for assigned manufacturing systems, computerized systems, packaging equipment, facility assets, utilities, and infrastructure.
- Maintain assigned systems in a qualified, compliant, reliable, and inspection-ready state throughout their lifecycle.
- Develop, maintain, and update engineering documentation including specifications, engineering assessments, lifecycle documentation, and technical reports.
- Review and support preventive maintenance strategies, calibration programs, engineering changes, and system improvements.
- Monitor system performance and implement reliability, operational excellence, and continuous improvement initiatives.
- Maintain computerized systems in compliance with applicable regulatory requirements, including vulnerability assessments and system lifecycle documentation.
- Support deployment and lifecycle activities for manufacturing technology projects, including operating system upgrades, endpoint management migrations, and infrastructure modernization initiatives.
- Provide technical ownership of SAP-integrated operational systems supporting shipping interfaces, label printing, scale connectivity, report tracking and automated packaging workflows.
- Manage business applications by supporting incident resolution, problem management, troubleshooting, and continuous system improvements.
Manufacturing and Packaging Support
- Support manufacturing operations, secondary packaging processes, and shipping systems.
- Provide engineering support for labeling systems, barcode technologies, automated vision inspection systems, printers, scanners, and packaging automation.
- Troubleshoot technical issues affecting manufacturing and packaging operations while implementing sustainable engineering solutions.
- Support manufacturing process improvements that enhance equipment reliability, operational efficiency, and product quality.
Quality and Compliance
- Perform technical investigations and root cause analyses using structured problem-solving methodologies.
- Support Change Control activities by performing engineering impact assessments, risk evaluations, and qualification assessments.
- Ensure engineering activities comply with GMP regulations, corporate engineering standards, and applicable regulatory requirements.
- Maintain documentation in accordance with Good Documentation Practices (GDP) and quality system expectations.
Project Support
- Support capital projects, equipment upgrades, infrastructure improvements, and manufacturing system enhancements.
- Participate in project planning, design reviews, commissioning, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), qualification, startup, and project turnover.
- Author, review, and execute validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, engineering rationale documents, and validation summary reports.
- Review engineering designs and contractor deliverables to ensure compliance with regulatory, engineering, and business requirements.
- Coordinate validation and implementation activities with Engineering, Quality Assurance, Manufacturing, Automation, Supply Chain, and external contractors.
- Support project execution to achieve scope, schedule, budget, and quality objectives.
- Support implementation of SAP-integrated operational workflows and business process improvements.
- Audits and Inspection Readiness
- Support internal audits, customer audits, and regulatory inspections as the engineering subject matter expert for assigned systems.
- Present engineering documentation, validation packages, technical assessments, and qualification strategies during inspections.
- Support responses to audit observations and engineering-related quality actions.
- Maintain assigned systems and engineering documentation in a continuous state of inspection readiness.
Cross-Functional Collaboration
- Partner with Quality, Manufacturing, Automation, Maintenance, Validation, Supply Chain, EHSS, and Information Systems to support site objectives.
- Collaborate with global engineering and technology teams during lifecycle projects and system deployments.
- Promote continuous improvement, operational excellence, and engineering best practices.
- Share technical knowledge and support the development of engineering solutions across functional teams.
Qualifications
Basic Qualifications
- Bachelor's degree in engineering, Computer Engineering, Electrical Engineering, Mechanical Engineering, Industrial Engineering, Computer Science.
OR
- Master's degree in an engineering or related technical discipline.
Preferred Qualifications
- Experience supporting GMP manufacturing or pharmaceutical operations.
- Knowledge of equipment lifecycle management and System Ownership principles.
- Understanding of GMP, data integrity, computerized system validation, and change control processes.
- Experience supporting manufacturing automation, packaging equipment, or industrial control systems.
- Experience participating in commissioning, qualification, and validation activities.
- Strong troubleshooting, analytical, and problem-solving skills.
- Excellent written and verbal communication skills with the ability to work effectively across cross-functional teams.
Technical Skills
Experience or familiarity with:
- SAP ERP
- ServiceNow
- Microsoft Windows Operating Systems (Windows 10/11)
- Zebra printers
- Domino printers
- Industrial barcode scanners
- Label printing systems
- Automated vision inspection systems
- Packaging automation equipment
- Manufacturing IT infrastructure
- Computerized System Validation (CSV)
- GMP documentation practices
- Core Competencies
- Technical problem solving
- System ownership and accountability
- Continuous improvement mindset
- Cross-functional collaboration
- Customer focus
- Attention to detail
- Regulatory compliance
- Project execution
- Communication and technical documentation
- Learning agility
