Position Summary:
We are seeking a Contractor Project Engineer to lead and execute labeling update projects supporting the Project Engineering Department within a regulated medical device manufacturing environment. This role partners closely with Project Engineering, Quality, Regulatory Affairs, Operations, and other cross-functional teams to implement labeling changes, coordinate project activities, execute validation efforts, and ensure compliance with quality and regulatory requirements.The specialist will be responsible for managing labeling-related change controls, assessing risks and compliance impacts, validating labeling equipment and systems as required, and driving projects from initiation through implementation and closure. The ideal candidate is a hands-on professional with strong project management, technical writing, problem-solving, and communication skills, along with a continuous improvement mindset.Candidates must be proficient in English (written and verbal) and be available to support multiple shifts and weekend activities as business needs require.

Key Responsibilities:

• Lead and execute labeling update projects, ensuring timely implementation and compliance with applicable regulatory and quality requirements.
• Manage labeling-related change control activities from initiation through closure, including implementation planning, documentation updates, verification, stakeholder communication, and effectiveness checks.
• Coordinate cross-functional activities with Quality, Regulatory Affairs, Operations, Manufacturing, Supply Chain, Product Development, Engineering, and IT teams.
• Author, review, and execute validation documentation, including validation plans, protocols, test scripts, reports, risk assessments, and impact assessments, as required.
• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for labeling equipment, printing systems, software, and related processes, when required.
• Support qualification and implementation of new label materials, printers, barcode systems, vision systems, and labeling software, when required.Investigate and resolve issues encountered during labeling updates, validation activities, or implementation efforts.
• Assess existing labeling processes and documentation as required, identify risks, gaps, and compliance concerns, and recommend corrective or preventive actions.
• Develop, maintain, and monitor project schedules using Microsoft Project and provide regular status updates to stakeholders, as required.
• Drive continuous improvement initiatives focused on labeling processes, project execution, compliance, and operational efficiency.
• Ensure all project documentation complies with company procedures, GMP requirements, quality system standards, and data integrity expectations.
• Utilize Microsoft Office applications to support project planning, reporting, documentation, data analysis, and presentations.

Required Qualifications:

• Bachelors degree in Industrial Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical discipline.
• Minimum of 5 years of experience in validation, labeling, quality, manufacturing, or other regulated industry environments.
• Demonstrated experience leading and executing labeling update projects.
• Experience with change control processes and project lifecycle management.
• Experience validating labeling equipment, including printers, barcode systems, vision systems, and labeling software.Working knowledge of FDA Quality System Regulations (QSR), ISO 13485, ISO 9001, GMP requirements, or equivalent regulated environments.
• Experience creating and executing validation protocols and reports.
• Experience using Microsoft Project for planning, scheduling, tracking, and executing projects.
• Experience with Product Lifecycle Management (PLM) systems such as Agile PLM and ERP platforms such as Oracle or equivalent systems.
• Strong analytical, problem-solving, risk assessment, organizational, and technical writing skills.
• Strong verbal and written communication skills and ability to work effectively within cross-functional teams.
• Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Project.
• Ability to work in ISO Class 7 and Class 8 cleanroom environments while wearing required gowning for extended periods.
• Ability to support multiple shifts and weekends, as required by project and operational needs.
• Demonstrated initiative, accountability, adaptability, and commitment to continuous learning.

Preferred Qualifications:

• Experience within the medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing industries.
• Knowledge of labeling regulations, validation methodologies, computerized systems validation, and quality systems.
• Knowledge of Project Management Tools (e.g. Microsoft Project) is preferred.
• Experience with electronic quality management systems (eQMS), document management systems, and ERP platforms.
• Bilingual proficiency in English and Spanish (written and verbal).

Key Competencies:

• Project Leadership
• Change Management
• Validation and Qualification
• Risk Assessment and Mitigation
• Regulatory Compliance
• Technical Documentation
• Cross-Functional Collaboration
• Problem Solving and Decision Making
• Continuous Improvement
• Time Management and Organization 

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $34.83/hr.